Devices and methods for ocular surgery

ABSTRACT

Devices, systems, and methods for performing an ophthalmic procedure in an eye are disclosed. The devices include a hand-held portion and a distal, elongate member coupled to the hand-held portion having a lumen operatively coupled to a vacuum source. A drive mechanism operatively coupled to the elongate member is configured to oscillate the elongate member. When in use, the device is configured to aspirate ocular material from the eye through the lumen. The drive mechanism retracts the elongate member with a retraction speed profile and advances the elongate member with an extension speed profile. The retraction speed profile is different from the extension speed profile.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119(e)to U.S. Provisional Patent Application Ser. Nos. 62/501,710, filed May4, 2017, and 62/597,826, filed Dec. 12, 2017. The disclosures of theprovisional applications are incorporated by reference in theirentireties.

FIELD

The present technology relates generally to devices and methods forocular surgery with one such procedure being removal of a lens from ahuman eye. More specifically, the technology relates to fragmenting,capturing, and extracting of lenticular or other tissue in ophthalmicsurgery.

BACKGROUND

Certain types of conventional ophthalmic surgery require breaking uplenticular tissue and solid intraocular objects, such as the intraocularlens into pieces so that it can be extracted from the eye. For example,extraction of lenses for cataract surgery is one of the most commonoutpatient surgical fields with more than 3 million cases performedannually in the United States alone. During cataract surgery a commonlyused method for lens extraction is phacoemulsification, whichincorporates using ultrasonic energy to break up the lens and thenaspiration to remove the lens fragments through the instrument. Othermethods of lens fragmentation and extraction may include the use ofinstruments such as hooks, knives, or laser to break up the lens intofragments and then extract through an incision in the cornea in an abinterno approach. Intraocular, ab interno fragmentation of thelenticular tissue is extremely important in cataract surgery in order toallow removal of cataracts from ocular incisions that are typically notexceeding 2.8-3.0 mm.

A disadvantage of some lens extraction techniques are unwantedcomplications from aspiration of the lens particularly with the use ofphacoemulsification. Ultrasonic energy and high volume duringphacoemulsification may create turbulent flow that may have adeleterious effect on the tissue within the eye such as the cornealendothelium.

Additionally, certain aspiration and inspiration configurations requirelarge pieces of capital equipment as in the case of phacoemulsificationor may require certain resources such as wall vacuum that may not beavailable in all surgical settings, particularly in underdevelopedareas. Convention aspiration devices may be an independent tube orcannula or may be associated with another device such as aphacoemulsification unit (“phaco system”). Flow control and pressurecontrol of phaco systems typically requires electronic control by a mainconsole. A hand piece is used that has a suction line extending from thehand piece to the main console. The hand piece also typically has aninspiration line with inspiration driven by simple gravity feed or byflow controlled by the main console with a fluid bag/cartridge mountedto the console.

Another problem with phaco devices and other devices using a remotevacuum source is that the suction lines are long that means that theywill often contain compressible material during the procedure, such asgas or compressible tissue. Long suction lines of compressible materialaffects the responsiveness of suction at the tip when suction is turnedon and off. The problem of responsiveness is exacerbated by manuallydeformable/compliant hoses and lines that also respond to changes inpressure when starting and stopping suction, which further delaysinitiation and termination of suction at the tip. Yet another problemwith some systems is that the disposal enclosure is also exposed tovacuum pressure and, as such, the container and gas or othercompressible material therein, also responds to changes in pressure andfurther contributing to the delay in initiation and termination ofsuction at the tip and contributing to the low responsiveness of somesystems.

Still another problem with conventional methods and devices foraspirating material from the eye is that the suction opening can readilyclog during the procedure. Suction must be stopped and, if necessary,the material removed independently with another instrument inside theeye. The necessity to stop the procedure and unclog the distal openingundesirably increases the procedure time and need for unnecessarymanipulations of the instrument(s) in the eye.

A final problem with some devices is the cost and complexity of thesystems. A lower cost alternative with the same or better performancewould also be desirable alternative such as one not requiring a costlycontrol console and electronic control system.

SUMMARY

In an aspect, described is device for performing an ophthalmic procedurein an eye, the device includes a hand-held portion and a distal,elongate member coupled to the hand-held portion. The distal, elongatemember includes a lumen operatively coupled to a vacuum source. Thedevice includes a drive mechanism operatively coupled to the elongatemember and configured to oscillate the elongate member. When in use, thedevice is configured to aspirate ocular material from the eye throughthe lumen and the drive mechanism is capable of retracting the elongatemember in a proximal direction with a retraction speed profile andadvancing the elongate member in a distal direction with an extensionspeed profile. The retraction speed profile is different from theextension speed profile.

An average retraction speed of the elongate member from the retractionspeed profile can be lower than an average extension speed of theelongate member from the extension speed profile. The drive mechanismoperatively coupled to the elongate member can be configured toasymmetrically oscillate the elongate member. The extension speedprofile can include a maximum extension speed and the retraction speedprofile can include a maximum retraction speed. The maximum retractionspeed can be less than the maximum extension speed. The maximumretraction speed of the elongate member can be below a threshold speedat which cavitation bubbles would be generated in the eye.

A distal tip of the elongate member can be configured to move relativeto the hand-held portion from a fully retracted configuration to a fullyextended configuration to define a travel distance. The travel distancecan be between approximately 0.05 mm and 1.0 mm. A pulse of aspirationcan be drawn through the lumen of the elongate member during at least aportion of the travel distance as the elongate member advances in thedistal direction. A pulse of aspiration can be drawn through the lumenof the elongate member during at least a portion of the travel distanceas the elongate member retracts in the proximal direction. The devicecan further include an actuator configured to adjust the traveldistance. The actuator can be configured to be mechanically adjusted bya user.

The device further include a control processor responsive to user input.The control processor can control one or more aspects of the drivemechanism. The one or more aspects can include the travel distance, anaspiration pulse frequency, or a frequency of an extension andretraction cycle. The control processor can be programmable and acceptuser input to adjust at least one aspect of the extension speed profileand the retraction speed profile. The control processor can beprogrammable and accept user input to adjust at least one of a maximumextension speed and a maximum retraction speed. The control processorcan be programmable and accept user input to set a retraction speedlimit. The control processor can be programmable and can be configuredto be programmed by an input on the device. The control processor can beprogrammable and can be configured to be programmed remotely by anexternal computing device. The control processor can operate accordingto program instructions stored in a memory, the program instructionsdefining at least one of the extension speed profile of the elongatemember and the retraction speed profile of the elongate member. Thememory storing the program instructions can include a portion of aphacoemulsification system. At least one of the extension speed profileof the elongate member and the retraction speed profile of the elongatemember can be adjustable through one or more changes to hardware, thehardware in operable communication with the control processor. Thehardware can include a portion of a phacoemulsification system.

The drive mechanism can be pneumatic, electromagnetic, piezoelectric, ormechanical. The drive mechanism can include a piezoelectric elementconfigured to oscillate the elongate member according to a voltagefrequency that forms a non-sinusoidal motion pattern of the elongatemember. The voltage frequency sent to the piezoelectric element can havea generally non-sinusoidal waveform. The voltage frequency sent to thepiezoelectric element can include two or more overlapping sinusoidalwaveforms configured to create an interference forming a generallynon-sinusoidal waveform. The voltage frequency can contract thepiezoelectric element slower than the voltage frequency allows thepiezoelectric element to expand.

The drive mechanism can include a cam mechanism operatively coupled tothe elongate member. A first amount of rotation of the cam mechanism canretract the elongate member in the proximal direction along theretraction speed profile. A second amount of rotation of the cammechanism can advance the elongate member in the distal direction alongthe extension speed profile. The retraction speed profile can be atleast in part a function of a rotational speed of the cam mechanism. Thedrive mechanism further can include a spring configured to be compressedby the cam mechanism. The first amount of rotation of the cam mechanismcan compress the spring and the second amount of rotation of the cammechanism can release the spring from compression. The extension speedprofile can be a function of a force of the spring and a mass of theinner elongate member.

The elongate member can include a wall and a port through the wall, theport having a cutting surface. The elongate member can include a cuttingtip. The cutting tip can be beveled. The cutting tip can include adistal opening from the lumen having a first dimension, the firstdimension smaller than a second inner, cross-sectional dimension of thelumen of the elongate member. The distal opening of the cutting tip canhave a first area, the first area smaller than a second innercross-sectional area of the lumen of the elongate member.

The device further can include an outer tube comprising an outer tubelumen. The elongate member can be positioned within the outer tubelumen. The ocular material can be aspirated through the outer tubelumen. The ocular material can be aspirated through both the outer tubelumen and the lumen of the elongate member. The device can furtherinclude an outermost tube having an outermost tube lumen. The outer tubecan be positioned within the outermost tube lumen. The outermost tubecan include one or more ports for delivering irrigation fluid to theeye. The outermost tube can include an elastic material.

The elongate member can be capable of being repeatedly advanced andretracted along a longitudinal axis of the elongate member. The elongatemember can be capable of being repeatedly advanced and retracted alongan elliptical pathway relative to a longitudinal axis of the elongatemember. The elongate member can be capable of being repeatedly advancedand retracted along a non-linear pathway relative to a longitudinal axisof the elongate member. The non-linear pathway can be curvilinear. Thenon-linear pathway can be elliptical. The elongate member can betorsionally oscillated. The extension speed profile can include a firstangular rotational speed profile produced through being torsionallyoscillated. The retraction speed profile can include a second, differentangular rotational speed profile.

The vacuum source can deliver a pulsed vacuum to a distal portion of thelumen of the elongate member. The vacuum source can be located within ahousing of the hand-held portion. The vacuum source can be located on ahousing of the hand-held portion. The drive mechanism can be repeatedlyadvanced and retracts the elongate member while the vacuum sourcedelivers the pulsed vacuum. After the elongate member completes a singlecycle of one advancement and one retraction, the vacuum source candeliver at least one pulse of vacuum to the distal portion of the lumen.As the elongate member passes through a single cycle of one advancementand one retraction, the vacuum source can deliver a plurality of pulsesof vacuum to the distal portion of the lumen. After each pulse ofvacuum, the device can produce a pulse of positive-pressureregurgitation. As the elongate member passes through an oscillationcycle of one advanced and one retraction, the vacuum source can deliverat least one pulse of vacuum to the distal portion of the lumen. As theelongate member retracts during the oscillation cycle, the vacuum sourcecan deliver at least one pulse of vacuum to the distal portion of thelumen. As the elongate member advances during the oscillation cycle, thevacuum source can deliver at least one pulse of vacuum to the distalportion of the lumen.

The ocular material can include at least one of fragmented lens materialor emulsified lens material. The ocular material can include vitreousmaterial. The drive mechanism can be configured to oscillate theelongate member at a frequency of oscillation that is ultrasonic. Thedrive mechanism can be configured to oscillate the elongate member at afrequency of oscillation that is greater than about 20,000 Hz. The drivemechanism can be configured to oscillate the elongate member at afrequency of oscillation that is between about 0.5 Hz and about 5000 Hz.The frequency of oscillation can be selectable by a user through aninput to a control processor, the control processor being in operativecommunication with the drive mechanism.

In an interrelated aspect, described is a method for performing anophthalmic procedure in an eye. The method includes inserting a distalportion of a device into an anterior chamber of the eye and accessing alens of the eye with the distal portion of the device. The devicefurther includes a hand-held portion having a vacuum source configuredto create pulses of discontinuous negative pressure and to create pulsesof discontinuous positive pressure. The pulses of discontinuous negativepressure being interspersed by the pulses of discontinuous positivepressure and having a frequency. The device includes a distal, elongatemember coupled to the hand-held portion and forming part of the distalportion. The elongate member has an internal lumen and an opening at adistal end region of the elongate shaft. The method further includesactivating the device to create the pulses of discontinuous negativepressure through the internal lumen of the elongate member to aspirate afirst amount of material into the internal lumen through the opening atthe frequency, and to create the pulses of discontinuous positivepressure interspersed with the pulses of discontinuous negative pressureto expel, from the internal lumen through the opening, a second amountof material at the frequency. The second amount is substantially lessthan the first amount.

In an interrelated aspect, described is a device for performing anophthalmic procedure in an eye including a hand-held portion and adistal, elongate member coupled to the hand-held portion. The distal,elongate member includes a lumen and an opening at a distal end regionof the elongate member. The device includes a vacuum source in fluidcommunication with the opening at the distal end region of the elongatemember. The vacuum source is configured to deliver pulses ofdiscontinuous negative pressure to the distal end region of the lumen.

The vacuum source can include a pump positioned within an interior ofthe hand-held portion. The pump can include at least one pumping chamberhaving an inlet opening and an outlet opening, the inlet opening influid communication with the lumen of the elongate member. The pump caninclude a piston positioned within the at least one pumping chamber; anda drive mechanism configured to oscillate the piston within the at leastone pumping chamber to create the pulses of discontinuous negativepressure. The negative pressure can be from 10 inHg up to about 30 inHg.The pulses of discontinuous negative pressure can have a cyclingfrequency of between about 1 Hz and about 100 Hz. A first pulse ofnegative pressure can draw a first amount of fluid from the lumen of theelongate member into at least one pumping chamber positioned within thehand-held portion through an inlet opening. A first pulse of positivepressure within the at least one pumping chamber can expel the firstamount of fluid from the at least one pumping chamber through an outletopening. A volume of the first amount of fluid can be between about 0.1mL up to about 1.0 mL. Movement of a piston in a first direction withinthe at least one pumping chamber can create the first pulse of negativepressure. Movement of the piston in a second, opposite direction cancreate the first pulse of positive pressure. A compliant valve can bepositioned within the inlet opening. Movement of the piston a seconddistance in the second, opposite direction can seal the inlet openingand transmit an amount of the first pulse of positive pressure throughthe compliant valve to the lumen of the elongate member. The amounttransmitted can cause a second amount of fluid to be expelled out theopening at the distal end region of the elongate member. The outletopening can be regulated by a valve. The valve can be a ball type checkvalve. The outlet opening can be in fluid communication with anevacuation chamber.

The device can further include a drive mechanism operatively coupled tothe elongate member and configured to oscillate the elongate member. Inuse, the drive mechanism can retract the elongate member in a proximaldirection with a retraction speed profile and advance the elongatemember in a distal direction with an extension speed profile. Theretraction speed profile can be different from the extension speedprofile. An average retraction speed of the elongate member from theretraction speed profile can be lower than an average extension speed ofthe elongate member from the extension speed profile. The drivemechanism operatively coupled to the elongate member can be configuredto asymmetrically oscillate the elongate member. The extension speedprofile can include a maximum extension speed and the retraction speedprofile can include a maximum retraction speed. The maximum retractionspeed can be less than the maximum extension speed. The maximumretraction speed of the elongate member can be below a threshold speedat which cavitation bubbles would be generated in the eye. A distal tipof the elongate member can be configured to move relative to thehand-held portion from a fully retracted configuration to a fullyextended configuration to define a travel distance.

In some variations, one or more of the following can optionally beincluded in any feasible combination in the above methods, apparatus,devices, and systems. More details of the methods, apparatus, devices,and systems are set forth in the accompanying drawings and thedescription below. Other features and advantages will be apparent fromthe description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will now be described in detail with referenceto the following drawings. Generally speaking, the figures are not toscale in absolute terms or comparatively, but are intended to beillustrative. Also, relative placement of features and elements may bemodified for the purpose of illustrative clarity.

FIG. 1 shows a device for suctioning material.

FIG. 2 shows another device for suctioning material.

FIG. 3A shows still another device for suctioning material.

FIG. 3B shows an alternative suction source using a bellows.

FIG. 4 shows yet another suction device using a venture.

FIG. 5 shows still another suction device having a bladder as thesuction source.

FIG. 6A shows a flow restrictor covering an opening in a shaft and in astored position in the dotted-line position.

FIG. 6B shows the flow restrictor movable longitudinally relative to theshaft with the dotted line position showing a working position.

FIG. 6C shows show an alternative shaft having a y-arm.

FIG. 7 shows an end view of the flow restrictor.

FIG. 8A shows a tissue manipulator in a collapsed position within alumen of a shaft.

FIG. 8B shows the tissue manipulator expanded with filaments extendingbetween loops.

FIG. 8C shows another view of the loops with the filaments removed.

FIG. 9 shows another tissue manipulator with integrally formedintermediate elements.

FIG. 10 shows another tissue manipulator with integrally formedintermediate elements.

FIG. 11 shows still another tissue manipulator with a net-like materialwithin the loops.

FIG. 12 shows still another tissue manipulator having a loop with anintegrally formed concave element.

FIG. 13 shows still another tissue manipulator with a rotating cutter.

FIG. 14 shows another tissue manipulator with a net-like material.

FIG. 15 shows still another tissue manipulator.

FIG. 16 shows a tissue manipulator having two opposing baskets.

FIG. 17 shows the opposing baskets in a nested position.

FIG. 18A shows a device for cutting material within the eye.

FIG. 18B shows a side view of the device of FIG. 18A.

FIG. 18C shows the device of FIG. 18A with an elongate element deformedto expand a loop formed by the device.

FIG. 18D shows the device of FIG. 18C further expanded.

FIG. 19 shows the device of FIGS. 18A-18D full expanded and positionedwithin a capsular bag and advanced between the capsular bag and the lenswhen the loop is expanded.

FIG. 20A shows another cutting device in a collapsed position.

FIG. 20B shows the device of FIG. 20A partially expanded with the distalend changing orientation with respect to the proximal end of the shaft.

FIG. 20C shows a loop formed by the device advancing distally.

FIG. 21A shows the loop expanded further.

FIG. 21B shows the loop expanded with the proximal end of the elongateelement also changing orientation with respect to the shaft.

FIG. 22A shows another device for aspirating material from an eye with avalve along the suction path in a closed position.

FIG. 22B shows the device of FIG. 22A with the valve in an openposition.

FIG. 23A shows an actuator having a foot pedal in a resting or offposition.

FIG. 23B shows the actuator in the fully on position.

FIGS. 24A-24B shows two views of an alternative embodiment with anadjustable stop for defining a maximum distal displacement of the valve.

FIGS. 25A-25B shows two views of another alternative embodiment with anadjustable stop in the form of a cam.

FIG. 26 shows a retrograde flow element positioned in a retrogradechannel that is coupled to the main lumen.

FIGS. 27A-27B show cross-sectional views of an implementation of adevice for cutting and aspirating material from an eye.

FIGS. 27C-27D show view of the cutting tool of the device of FIGS.27A-27B.

FIGS. 27E-27H show various perspective views of a barrel cam of thedevice of FIGS. 27A-27B.

FIGS. 28A-28B show side views of an implementation of a device forcutting and aspirating material from an eye.

FIGS. 28C-28D show cross-sectional view of the device of FIGS. 28A-28Btaken along line C-C and D-D, respectively.

FIGS. 28E-28G show various view of a rotating cam of the device of FIGS.28A-28B.

FIGS. 28H-28N are additional views of various components of the deviceof FIGS. 28A-28B.

FIGS. 29A and 29B is a perspective view and a cross-sectional view,respectively, of an interrelated implementation of a device for cuttingand aspirating material from an eye.

FIG. 29C is a perspective view of an elongate member coupled to animplementation of an oscillating drive mechanism.

FIGS. 29D-29F are side views of the oscillating mechanism of FIG. 29C invarious stages of rotation.

FIGS. 29G and 29H are partial views of an elongate member having innerand outer tubes in an extended and a retracted state, respectively.

FIG. 30A shows a symmetric, sinusoidal motion profile of an elongatemember of conventional phacoemulsification systems.

FIG. 30B shows an asymmetric, non-sinusoidal motion profile of anelongate member.

FIG. 30C shows a symmetric motion profile for an elongate member wherean extension speed profile is the same as a retraction speed profile ofthe elongate member.

FIG. 30D shows an asymmetric motion profile for an elongate member wherean extension speed profile differs from a retraction speed profile ofthe elongate member.

FIGS. 30E-30F show additional examples of extension speed profiles andretraction speed profiles of an elongate member where the profiles aredifferent.

FIG. 30G shows a non-sinusoidal movement of the distal tip of anelongate member (bottom panel) relative to its extension speed profile(top panel).

FIG. 31A shows an implementation of a vacuum profile.

FIGS. 31B-31C show overlap between an asymmetric, non-sinusoidal motionprofile for an elongate member (solid line) and a vacuum profile foraspiration through the elongate member (hatched line).

FIG. 32A shows a perspective view of a device having an elongate member.

FIG. 32B is a detailed view of FIG. 32A taken along circle B-B.

FIGS. 33A-33C illustrate various stages of actuation of a device havingan elongate member.

FIGS. 34A-34C illustrate partial views of the device of FIGS. 33A-33C inthe various stages of actuation.

FIGS. 35A-35C illustrate partial views of the device of FIGS. 33A-33C inthe various stages of actuation.

It should be appreciated that the drawings are for example only and arenot meant to be to scale. It is to be understood that devices describedherein my include features not necessarily depicted in each figure.

DETAILED DESCRIPTION

Described herein are methods and devices for intraocular fragmentationand removal of the lens and other tissues during intraocular surgery.The devices described herein allow for extracting tissue from theanterior chamber without damaging other ocular structures. The devicesand methods described herein are capable of inspiration or aspirationwith less capitally intensive equipment.

In various embodiments an ocular surgical device is described that usescutting strings, filaments, snares, baskets, bags, loops and otherdevices designed to engage and fragment the lenticular tissue and aid inits removal from the eye in a minimally invasive, ab-interno approach.In other embodiments, described are devices and methods for inspirationand aspiration of fluids from the eye. The aspiration devices describedherein have improved responsiveness as compared to devices using remotesuction with long manually deformable/compliant suction lines. In oneaspect, provided is a hand-held device that can also be powered(manually) by the user and does not require electronic control. Thedevice can further have a short suction path with a small suctionvolume. The device can include a hand-held suction source therebyeliminating the need for hoses from the hand piece to the console. Thisgreatly reduces the length of line and also the amount of materialsubject to the suction pressure that can compress or expand to reduceresponsiveness. In some implementations, the devices described hereincan be “all-in-one” devices providing cutting, fragmenting, infusing,and/or aspirating functions all within the same hand-held device.

The devices described herein can include a purging mechanism that purgesthe material from the suction path and into the disposal enclosure. Thepurging mechanism may be part of the suction device or may be a separatemechanism. In a specific aspect, the purging mechanism is a plunger thatpushes the material in direction opposite the suction direction and intothe disposal enclosure. A valve, which may be a one-way valve, permitsthe material to enter the disposal enclosure. The valve (or one-wayvalve) may also prevent the material from entering the disposalenclosure when material is suctioned along the suction path during use.Purging the suction path during the procedure reduces the volume ofmaterial in the suction path compared to systems having long fluid linesto remote suction systems. Purging the suction line may occur in-betweensuction times and may be accomplished using a movable element that alsocreates the suction pressure. In a specific aspect, the movable elementmay be a spring-loaded plunger that is manually set.

In still another aspect, the suction device may include a movableelement within the suction path. For example, the suction device may bethe spring-loaded plunger that is manually actuated. Other suctiondevices are considered herein, including a pneumatic system withbladders and/or balloons, a deformable wall and roller system, or anyother suitable system for creating suction pressure such as a venturi.The movable element of the suction device may also be used to purge thesuction path but the two functions may be separated and performed indifferent manners.

In still another aspect, a valve may be coupled to the hand held unitand positioned along the suction path. The valve is coupled to a wireand a spring acts on the valve to bias the valve closed. The wire iscoupled to an actuator that may include a foot pedal to control movementof the wire and the valve. The foot pedal is also operably coupled tothe suction source so that movement of the foot pedal by the usercontrols the vacuum source. When the actuator is initially actuated (bypressing the foot pedal), the actuator moves the valve to a partiallyopen position during a first phase of displacement. The actuatorcontrols the vacuum or suction source to gradually increase the vacuumpressure as the actuator displacement increases during the first phase.During the first phase, the suction pressure may be increased to atarget or maximum pressure that may be at least 570 mm Hg. Statedanother way, the actuator controls the valve to be no more than halfopen until a target pressure is reached during the first phase ofdisplacement. The actuator may have a second phase of displacement thatfollows the first phase. The second phase may be carried out by with thevalve progressively opening from the partially open position to increasethe cross-sectional flow area as the actuator increases in displacement.Alternatively, during the second phase, the actuator controls the valveto increase and decrease the suction pressure exerted at the opening(and the flow rate) in a cyclic manner at a rate of at least 1 Hz in anysuitable manner such as moving the valve (as discussed below) betweenthe first position and the second positions. The second phase may becarried out with the suction pressure being constant and may also be atmaximum.

The actuator may also have a third phase of displacement that followsthe second phase of displacement. In the third phase of operation thevalve is moved between an initial (or first) position and a secondposition at a varying duty cycle to modulate the time-average flow ratewhile the suction source pressure may remain constant and/or maximized.The first position has a smaller cross sectional flow area than thesecond position. As greater flow is required by the user the time thevalve is held in or nearer to the second position increases. Thiscorresponds to an increased duty cycle between the two positions withthe duty cycle of the second position increasing relative to the firstposition. A pulse rate of at least 1 Hz may be appropriate. Statedanother way, the shift in the duty cycle during the third phase causesthe valve to increase a time that the valve is nearer to the secondposition than to the first position as the displacement of the actuatorincreases. Alternately, the same effect can be achieved keeping thepulse rate duty cycle constant but increasing the displacement of theactuator during the third phase by increasing the distance between thefirst position and the second position so that more of the aperture isexposed during each cycle and, therefore, typically a higher volume flowrate is achieved. The increase in displacement of the actuator causesthe second position of the valve during the third phase to define anincreasing cross-sectional flow area. Stated another way, the increasein displacement of the actuator during the third phase increases adistance between the first position and the second position so that moreof the aperture is exposed and, therefore, typically a higher volumeflow rate of suction is achieved.

The devices and methods described herein can reduce the likelihood ofclogging by providing a restrictor that restricts material in thevicinity of the distal opening. The restrictor reduces the likelihood ofclogging by restricting the material that can enter the distal opening.The restrictor may also be movable (longitudinally and/or rotationally)to clear material from in and around the opening and to gather materialas well. It should be appreciated that the devices can also include anelongate member having a distal tip having a reduced inner diametercompared to an inner diameter of regions proximal to the distal tip.Clogging can be mitigated by narrowing the size of the opening at thedistal tip compared to the size of the lumen.

Described herein is a tissue manipulator and method of manipulatingtissue. The tissue manipulator has a shaft having a lumen with a distalopening. A first loop has a first leg and a second leg with at least oneof the first and second legs extending through the lumen. The first loopis movable from a collapsed position to an expanded position when the atleast one of the first and second legs is advanced through the lumen andout the distal opening in the lumen. A second loop has a first leg and asecond leg with at least one of the first and second legs extendingthrough the lumen. The second loop being movable from a collapsedposition to an expanded position when the at least one of the first andsecond legs is advanced through the lumen and out the distal opening inthe lumen. The shaft may be sized for introduction of a distal end ofthe shaft into an eye.

The first loop may have an unbiased shape that bounds an area defined inan orientation that maximizes the area. The area has an effectivediameter that is equal to the diameter of a circle having the same area.The first loop moves toward the unbiased shape when moving from thecollapsed position to the expanded position. The effective diameter ofthe area of the first loop is 4.5 mm to 6.5 mm or can be 5.0 mm to 6.0mm in the expanded position. The effective diameter of the unbiasedshape of the second loop may be within 20% of an effective diameter ofthe expanded position of the first and/or second loops. In this manner,the first and/or second loops provide for a soft deployment and areflexible during use. Use of a superelastic material further enhances theflexibility of the first and second loops. To this end, the first andsecond loops may be formed of superelastic wire having a diameter ofabout 0.003″ to about 0.006″ although any size may be used with anysuitable cross-sectional shape.

The tissue manipulator may also include an intermediate elementpositioned between the first loop and the second loop. The intermediateelement may be a third loop positioned between the first loop and thesecond loop. The intermediate element may include an interconnectingelement extending between the first loop and the second loop. Theinterconnecting element may be integrally formed with the first loop andthe second loop. Alternatively, the interconnecting element may be aflexible filament extending between the first loop and the second loop.The third loop may have the features of the first and second loops.

The first and second loops provide a controlled amount of exposedsurface therebetween to control, and optionally cut, a controlled amountof the material. The exposed surface between the first loop and thesecond loop has an area of 15 mm³ to 60 mm³. Stated another way, theexposed surface between the first loop and the second loop is 3-10 timesthe effective diameter in the expanded position (or the unbiasedposition since they may be the same). The exposed surface between thefirst loop and the second loop may have 2-8, 2-6, 2-4 or even just 2independent cells when viewed in a radially inward direction relative tothe orientation axis of the first and second loops. The exposed surfacehas an area that is at least 4 times larger than a surface area of theintermediate element when expanded between the first and second loopsand viewed radially inward with respect to the loops. In this manner,the intermediate element does not take up an excessive amount of room ascompared to some net-type devices.

The device may include a first support element extending from a distalend of the shaft when the first loop is expanded. The first supportelement may be an elongate element that extends to a free end. The firstsupport element is positioned with the free end positioned within anarea of the first loop when viewing the first loop along an orientationthat maximizes the area of the first loop. A second support element thatcooperates with the second loop in the same manner may also be provided.The first loop and/or second loop may have at least one interconnectingelement extending from a first connection to the first loop to a secondconnection to the first loop or may be substantially free of any suchinterconnecting elements depending upon the desired use.

In yet another aspect, the tissue manipulator can have a concave elementcoupled to a first loop to form a basket. The concave element may haveone end integrally formed with the first loop with the other end movablewithin the lumen independent of the first and second legs.Alternatively, both ends may be integrally formed with the loop. Asecond loop having another concave element may be provided to formanother basket with the two baskets being movable relative to oneanother between a nested position and a position in that the two basketsoppose one another.

In use, the device is introduced into the eye with a distal end anddistal opening of the shaft inside the eye. The first loop is expandedand the second loop is also expanded (simultaneously or independently).Material is positioned within the first and/or second loop and then thefirst and/or second loop is collapsed around the material to contain,manipulate or cut the material. Furthermore, a suction source may becoupled to the lumen to suction the material, fluid, and the cutmaterial into the lumen or another lumen. The method may include allfeatures of the device that are expressly incorporated here for allpurposes.

Another device is provided that has a shaft having an elongate elementthat is bowed outwardly by biasing the elongate element with a load whendeployed. The loop is movable from a collapsed position to an expandedposition when a first shaft part (coupled to the first end of theelongate element) and a second shaft part (coupled to the second end ofthe elongate element) are moved relative to one another from a firstposition to a second position. Material is positioned in the loop andthen cut by collapsing the loop. The loop may be expanded so that theloop advances between the capsular bag and a whole lens contained withinthe capsular bag.

The elongate element may have a first and a second flexible portion withan intermediate portion therebetween that is at least 1.5 more stiff inbending than the flexible portions. In another aspect, the first end maychange in orientation relative to the proximal end of the shaft whendeployed. The change in orientation may be provided by simply pinning orotherwise rotatably coupling the first end to the shaft so that theangle (orientation) changes by at least 120 degrees or 180 degrees+/−45degrees when the first and second shaft parts move from the firstposition to the second position. The distal end of the shaft may alsoinclude a flexible portion that changes in orientation relative to theproximal portion of the shaft when the loop is expanded. The distal endmay change in orientation by at least 30 degrees. The first end rotatesso that the loop advances distally beyond a distal end of the shaft asthe loop moves from the collapsed position to the expanded position. Thesecond end may also be rotatably coupled to the shaft or may include theflexible portion. Use of and discussion of all aspects of the firstflexible portion or the first end are equally applicable to the secondend and are specifically incorporated herein. Furthermore, a mixture offirst end and second end are also expressly incorporated such as aflexible first end and a rotatable second end.

A plunger device may be depressed in order to create a vacuum to providesuction when connected to the hand piece. During cataract surgery it isdesirable to have a supply of balanced saline solution (BSS) deliveredto the eye as well as a supply of suction to remove fluids and othermaterials. Certain ophthalmic surgical tips have the ability toinspirate and aspirate fluid through dual lumen designs. These devicesare connected to a supply of suction and pressurized BSS fluid.Described herein are devices that include the ability to provide suctionor BSS pressurized fluid through simple mechanisms, some of which may bemanually powered or regulated. The hand piece may also be connected to apressurized BSS source such as a hanging bag or any number of otherpressurized sources such as spring loaded syringes and the like.Alternatively vacuum may be supplied by any number of other mechanismssuch as a bellows mechanism, diaphragm pump, venturi pump, entrapmentpump, positive displacement pump, regenerative pump, momentum transferpump, sealed containers of vacuum that are released, micro pumps, or thelike. When connected to a hand piece, suction is supplied to the tip toprovide aspiration. In one embodiment, a compressible bulb such as aturkey baster may be used to provide suction. The user may depress thebulb with a finger and control the amount of suction by the release ofthe finger from the bulb. Other lever mechanisms may additionally createvacuum in a hand held instrument. In some embodiments, a nurse orassistant may create vacuum with a device that is connected to the handheld instrument. For example, a foot pedal may be used to create suctionthat is connect to the surgeon's device. The hand piece may contain anynumber of waste containers that contain the withdrawn fluid and store itin the hand piece or off the hand piece. The various vacuum mechanismsmay be powered in any number of ways such as a manual operation by theuser or assistant. In this embodiment, the user may ‘charge’ the devicewith energy such as by depressing a spring loaded plunger beforebeginning the procedure and then controlling the amount of vacuum with avalve or other input mechanism. In some embodiments, the BSS pressurizedsupply may be coupled to the hand piece and may be ‘charged’ at the sametime as the vacuum or separately. For example, the surgeon may depressone plunger that creates a spring force on the vacuum and the BSS fluidsuch that the surgeon may control the release of both with a singlebutton or multiple buttons during the procedure. In other embodiments,the BSS may be in a hanging bag or other pressurized system and pipedinto the hand piece.

In some embodiments, the hand piece may include a flow control valve foradditionally allowing the surgeon to select the rate or pressure of thefluids aspirated or inspirated. The surgeon may adjust the amount offlow desired by rotating a knob that compresses a tube a certain amountor opens a ball valve a certain amount or any number of other flowcontrol mechanisms. The device may also include a button that can bedepressed to regulate when the device is inspirating or aspirating. Theamount the surgeon depresses the button may in itself control thevariable flow. There may be a single button for controlling inspirationand aspiration or individual buttons for each. Where a button isdescribed herein, it should be appreciated that the button can be amulti-way button to activate more than a single function. Similarly, thedevice can incorporate more than a single button to access the variousfunctions of the device (i.e. aspiration, inspiration, cutting, etc.) Itshould be understood that button simply means a control interface forthe user and that any number of interfaces may be contemplated.Additionally the control interface may be on the hand held device itselfor may be in another location. For example a foot pedal may be used tocontrol the flow or a separate device held with a different hand may beused.

In some embodiments, the device may include a dual lumen design forinspiration and aspiration. In other embodiments, there may be more than2 lumens or the lumens may be oriented concentrically.

In various other embodiments, device and methods for the removal orfragmentation of the lenticular tissue is described. Bags or meshes thatare attached to snares or loops may be incorporated to grab lenticulartissue that is either whole or partially fragmented. The bags and meshesmay be used to pull the tissue from the eye through a paracentesis. Insome embodiments, a separate tool may be inserted into the bag or meshafter a fragment of the lens is captured and the separate tool may beused to break the tissue into smaller fragments. For example, a spinningcutter instrument may be inserted either with a different device orthrough a lumen of the bag device to cut the tissue into smaller pieceswhile it is within the bag or container so that may be withdrawn throughthe paracentesis.

In other embodiments, various baskets are used to capture the lensmaterial and either pull it from the eye or further fragment thematerial into smaller pieces that may be aspirated. In each embodiment,the bags and meshes and baskets may be made of any number of materials.For example, Nitinol material may be used and shaped into the properorientation. Certain material such as Nitinol may be elastically changedbetween multiple shapes and used to enter the eye through a smallprofile and expand within the eye to capture the lens material. Anynumber of shapes are contemplated such as coin purses, expandingballoons, curved bags, and the like. The devices may be comprised anyplurality of materials such as stainless steel, Nitinol, biocompatibleplastics, and the like. Additionally, Nitinol may be used in either itssuper elastic state or shape memory state or both in multiplecomponents.

In some embodiments, cutter and augers and the like may be used tomechanically fragment the lens into multiple pieces. These devices mayadditionally include integrated suction for the aspiration of the lensmaterial.

The aspects mentioned above are applicable to all suitable embodimentsdescribed herein. Thus, use of Nitinol as described above is applicableto all suitable aspects concerning any cutting filament, element ordevice described herein. Similarly, any aspect of the aspiration devicedescribed above are equally applicable to all aspiration embodimentsdescribed herein. Finally, the features, aspects and methods of usingeach of the devices and methods is equally applicable to the otherdevices and methods described herein (including cutting) and all suchfeatures are expressly incorporated herein.

Referring now to the figures, FIG. 1 shows a device 2 for removingmaterial during procedures on the eye. The device 2 has a suction path 4that extends through a lumen 6 to an opening 8 from the lumen 6 at ornear a distal end 12 of the lumen 6. The opening 8 can be positioned inthe eye for removal of material from the eye, such as lens fragmentswithin a capsular bag. A suction source 14 can be coupled to the suctionpath 4 to draw material into the opening 8. The suction source 14 can bea manually-loaded spring 16 coupled to a plunger 29 having a slidingseal 18. Other suitable sources of suction are considered herein. Thesuction source 14 can be located within the hand-held portion of thedevice 2 near the distal end region providing for a short suction path 4and the benefits of such a short path and small suction volume withinthe suction path 4.

The suction path 4 can have a proximal suction volume 21 and a distalsuction volume 23. The proximal suction volume 21 may be substantiallyunder the influence of suction pressure by the suction source 14 at alltimes so that the system is prepared or “primed,” in a sense, to suctionmaterial at any time during a procedure. The proximal suction volume 21of the suction path 4 may be less than 25 ml and already under suctionpressure proximal to an actuator 20 of the device 2. The proximalsuction volume 21 can be defined by the volume of the suction path 4between the actuator 20 and the suction source 14 (in this case thesliding seal 18). The distal suction volume 23 of the suction path 4 isalso small since the actuator 20 is positioned relatively near theopening 8. In some implementations, the distal suction volume 23 may beless than 2 ml. The actuator 20 may be movable to a number of differentpositions and may be continuously variable to allow for the desiredamount of suction by the user. The term actuator 20 is used herein torefer to the element that acts on the suction path 4. The actuator 20may include one or more inputs such as a slider, switch, button, orother type of physical element configured to be manually or otherwiseactivated. The input may be located directly on the handheld componentof the device and interface directly with the actuator 20 or the inputmay be remote to the actuator 20. In some implementations, the buttonmay act directly on the actuator 20 and may also have elastic propertiesitself. The input, whether a slider, switch, button, or other type ofactuator, can be a multi-way input to access more than a single functionof the device or the device can incorporate a plurality of inputs eachwith the capability of actuating a particular function (i.e. aspiration,infusion, cutting, etc.).

The suction source 14 can include a movable element that can bedisplaced in a direction shown by arrow A to draw the material into theopening 8 and through the suction path 4. The movable element isdisplaced in an opposite direction to the direction A to move materialinto the suction path 4 into the disposal enclosure 40 as explained ingreater detail below. The configuration of the suction source 14 canvary. In some implementations, the suction source 14 can be hand-held inthat the movable element is part of a hand-held unit. The device alsomay have no electronic control and no electric powered parts and mayeven be powered by the user in that the spring 16 is manually loaded(extended). The movable element can include a plunger 29 having asliding seal 18. The spring 16 can be coupled to the plunger 29 tomanually load the movable element with a spring load. The configurationof the movable element can vary including a piston, a plug, stopper,ball or a movable part of a wall such as a bladder or balloon. Onceloaded, the plunger 29 and sliding seal 18 of the movable elementcontinuously exerts suction pressure until the spring 16 is completelyrelaxed or otherwise restrained.

The actuator 20 can serve as a valve for the suction path 4 and may acton a deformable part 31 of the suction path 4. The opening 8 can beexposed to suction pressure in that suction pressure may be applied byexposing the opening 8 to the suction pressure when activating theactuator 20. Alternatively, the opening 8 may be exposed to the suctionpressure when activating the suction device itself. For example, eventhe spring-loaded mechanism of the device 2 may be coupled to acontroller (not shown) so that suction pressure is applied and releasedand, when applied, exposes the opening 8 to suction pressure to drawmaterial into the opening 8. The actuator 20 may be continuouslyvariable by simply depressing more or less to deform more or less of thedeformable part 31 between at least two different open positions. FIG. 1shows a continuously variable actuator 20 between the fully open andfully closed positions by simply varying the amount the deformable part31 is deformed.

A disposal enclosure 40 is coupled to the suction path 4 to receivematerial from the suction path 4. A valve 42, such as a one-way valve,can be positioned between the disposal enclosure 40 and the suction path4. The valve 42 permits material to move to the disposal enclosure 40and isolates the disposal enclosure 40 during suction operation. Thevalve 42 may be an actuated valve or a passive one-way valve that opensand closes automatically as necessary, for example, upon increase influid pressure on one side of the valve 42 relative to the other. Thevalve 42 isolates the disposal enclosure 40 so that the compressibilityof the material does not affect the responsiveness of the system asdescribed herein. The suction path 4 may increase in diameter at partsoutside the eye similar to or the same as a syringe. Furthermore, thesuction path 4 may take any of a variety of shapes. The disposalenclosure 40 is configured to be supported independently, for example,by the table a traditional hanger, or any other suitable structure.Furthermore, the disposal enclosure 40 may be hand-held or remotelylocated. The disposal enclosure 40 has a disposal lumen 45 extendingfrom the suction path 4 to the disposal enclosure 40. As mentionedabove, the valve 42 (or one-way valve) isolates the disposal enclosure40 from the suction pressure thereby preventing any pressure response bythe disposal enclosure 40 during use.

The device 2 can be hand-held to a large extent in that the suction path4 is hand-held and the suction source 14 is hand-held as well. Thesuction source 14 need not include tubing or the like from the suctionmachine, but defines the mechanical source that is creating the suctionpressure. It should be appreciated that any of a number of suctionmechanisms are considered herein. For example, a roller with tubing, apneumatic system, a bladder or venturi may be used to create suctionpressure. The suction path 4 may also be more than half non-manuallydeformable or even at least 90% non-manually deformable. Most systemswith remote suction devices include manually deformable tubes and hosesthat may respond to pressure changes and can further reduceresponsiveness. The suction path 4 may be small to further improveresponsiveness. To this end, the suction path 4 may have a length(longitudinal) L of less than 20 cm or a volume of less than 25 ml andeven less than 15 ml.

As mentioned above, the devices described herein are particularly usefulfor removing material from the eye. As such, the lumen 6 may beappropriately sized. The suction path 4 includes a shaft 51 having thelumen 6. The lumen 6 is sized for introduction into the eye and has alongitudinal axis with a cross-sectional area of the outer perimeter (ordiameter) of the shaft 51 being no more than 0.8 mm² while the lumen hasa cross-sectional area of at least 0.28 mm².

The plunger 29 and sliding seal 18 can be operated to manually purge thesuction path 4. Purging the suction path 4 reduces the material in thesuction path 4 when suction is reinitiated. A purging mechanism 55 maybe the movable element (e.g. plunger 29 and sliding seal 18) or may be aseparate element that moves the material from the suction path 4 to thedisposal enclosure 40. In one aspect, the purging mechanism 55 moves thematerial through the suction path 4 in an opposite direction to suctionof material along the suction path 4 as shown by arrow A. The valve 42permits flow from the suction path 4 to the disposal enclosure 40 whenthe movable element is advanced. The purging mechanism 55 may alsoinclude an element separate from the movable element that forms part ofthe suction device 14 and may be completely independent of the suctionsource 14. As defined herein, the suction path 4 includes volumesoccupied by movable element. For example, the sliding seal 18 movesbetween fully retracted and fully advanced positions with the suctionpath 4 essentially changing in length and in volume. As used herein, thedefined length and volume of the suction paths shall be defined with theminimum volume contained therein by the suction source 14. Thus, thelength and volume is defined by the most advanced position of theplunger/movable element that minimizes the length and volume.

As described herein, “compressible” material such as a gas may alsorefer to the “expansibility” of the material in that suction pressureapplied to entrained gas and material may permit the gas and material toexpand slightly under the lower suction pressure (rather than compress).The compressibility (or expandability) of gasses and the effect onpressure responsiveness is typically deemed a problem of“compressibility” of gasses and is also so described herein and it isunderstood that this term also applies to the expandable nature ofgasses and materials. With respect to the hoses and lines, the abilityto resist compression by the suction pressure is a material propertyrelevant to the responsiveness of such systems with manually deformablematerials typically also responding mechanically to pressure variations.

Referring to FIG. 2, shows an interrelated device 102 for removingmaterial during a procedure. In this implementation, the suction source114 can include a plunger 103 that is manually loaded with a spring 105.The spring 105 can be loaded with a pivoting lever 107 attached to ahousing 109. The disposal enclosure 111 can be mounted to and within thehousing 109 such that it is hand-held with the device 102. Pressing thelever 107 advances the plunger 103 to purge the material in suction path4 to the disposal enclosure 111. A first valve 113 and a second valve115 (which may be one-way valves) permit suction through the lumen andpurging of material into the disposal enclosure 111.

The lever 107 may be selectively locked and unlocked once advanced orthe user may continue to apply pressure to the lever 107 to essentiallystop suction. When suction is desired again, the lever 107 may bereleased with variable pressure to vary the amount of suction produced.Alternatively, the first valve 113 may include an interface 120, such asa button, which is actuated to open and close the suction path. Theinterface 120 may act as an actuator described herein and separates aproximal volume 117 from a distal volume 119 of the suction path. Thefirst valve 113 may be formed over a deformable portion 131 of thesuction path along the valve 113 for use as described herein and allsuch uses of the deformable portion and actuator are expresslyincorporated here. The second valve 115 (which may be a one-way valve)regulates flow to the disposal enclosure 111. As shown in FIG. 1, asource of irrigation fluid 121 may also be coupled to the shaft 51 forirrigating the eye using a source of irrigation fluid 121. The source ofirrigation fluid 121 may be a gravity fed bag or part of a fluiddelivery system such as a phacoemulsification system. An irrigationlumen 123 has an opening 125 positioned in the eye for delivery theirrigation fluid.

Referring to FIGS. 3A-3B, another suction device 302 is shown whereinthe same or similar reference numbers refer to the same or similarstructure. The suction source 314 can include a movable element thatincludes a sliding seal 318 coupled to a plunger 329 manually loadedwith a spring 316. In this implementation, the suction source 314 isshown to be remote from the hand-held housing 330. The spring 316 isloaded manually. An irrigation source 121, such as a bag of balancedsaline solution, can be coupled to an irrigation lumen 323. A valve 325can control flow of the irrigation fluid. The actuator 320 is used inthe same manner as the actuator 20 above and suction path includes thedeformable portion 331 and all aspects and methods of these elements areincorporated expressly here. Purging of the suction path is alsoaccomplished in the same manner with the material moving into thedisposal enclosure 340 when the plunger 329 and sliding seal 318 areadvanced. A valve 342 may be provided in the same manner as describedabove for controlling the flow into the disposal enclosure 340 anddiscussion of these aspects are also incorporated here.

Referring to FIGS. 3A-3B, the suction source 314 may also include amovable element that is a bellows 350 (rather than the plunger) that maybe actuated by foot with a foot pedal. The bellows 350 are biased to anopen position so that the bellows 350 provides suction after the footpedal is depressed. Similar to other embodiments, when the bellows 350is compressed by the user's foot the material within the bellows 350,which also constitutes part of suction path as described herein, ismoved to the disposal enclosure 340.

Referring to FIG. 4, yet another suction device 402 is shown wherein thesame or similar reference numbers refer to the same or similarstructure. The device 402 has a venturi 406 coupled to a source ofpressurized gas 408. The venturi 406 directs the pressurized gas towardthe disposal enclosure 440 that also directs the material within suctionpath 404 also toward the disposal enclosure 440. The venturi 406 alsoacts as the suction source producing suction pressure along the suctionpath 404. The suction path 404 includes a chamber 415 in communicationwith the venturi 406 so suction pressure is created in the chamber 415by the venturi 406. The venturi 406 is opened and closed with a pivotinglever 421.

Referring to FIG. 5, another suction device 502 is shown wherein thesame or similar reference numbers refer to the same or similarstructure. The suction source 514 has a movable element 529 that is abladder 531 configured to be deformed manually by the user. Oncecompressed, compression is maintained on the bladder 531 to stop suctionand reduced to produce suction. Stated another way, the bladder 531 ismoved from an unbiased stated to a compressed state with the userreleasing compression to begin suctioning material into the opening 508.Movement of the bladder 531 from the unbiased state to the compressedstate may also move material from the suction path 504 (which includesthe internal volume of the bladder) to the disposal enclosure 540. Afirst valve 513 may also include an interface 520, such as a button, sothat the first valve 513 acts as the actuator described herein andseparates a proximal volume (i.e. proximal of the valve 513) from adistal volume (i.e. distal of the valve 513) of the suction path 504.The first valve 513 may be formed over a deformable portion of thesuction path 504 along the valve 513 as described herein. A second valve543 (which may be a one-way valve) regulates flow to the disposalenclosure 540. An irrigation source 547 may also be provided with aspring loaded delivery mechanism 549 coupled to an actuator (not shown).

All aspects and methods of the suction devices described herein areapplicable to the other suction devices and all such methods and aspectsare expressly incorporated for each from the others. For example, thesuction path length and volume as well as dimensions of the lumen andshaft are applicable to each of the other suitable embodiments describedherein.

Referring now to FIGS. 6A-6C and FIG. 7, a suction tip 600 is shown forsuctioning material from the eye. The suction tip 600, whether removableor integral to the device, can be positioned on a front end of thedevices described herein to restrict the material suctioned to a sizethat reduces issues with clogging. The suction tip 600 can include ashaft 602 with a lumen 604 extending through the shaft 602. A distalopening 608 in the shaft 602 has an area that is defined by an openingaxis OA that maximizes a size of the opening 608. The opening area OAmay be circular, oval or any other suitable shape. The opening area OAdefines an effective diameter defined as the diameter equivalent for acircle having the same area as the opening area. The distal opening 608in the shaft 602 can be smaller than an inner diameter of the lumen 604thereby mitigating issues with clogging inside the shaft 602.

The suction tip 600 also can include a restrictor 610 that extends overthe distal opening 608 when viewed along the opening axis OA. Therestrictor 610 has a support arm 612 extending from the shaft 602. Therestrictor 610 may have a stop 614 attached to the support arm 612 withthe stop 614 spaced apart from the distal opening and positioned overthe distal opening when viewed along the opening axis OA as shown inFIG. 7. The restrictor 610 is spaced apart from the distal opening 608between 0.80 to 1.10 times, or 0.85 to 1.00 times, the effectivediameter measured along the opening axis and aligned with the distalopening 608 when viewed along the opening axis OA. The restrictor 610also may optionally extend a short distance from the distal end of theshaft 602 so that it does not impede use. To this end, the restrictor610 may have a distal end 615 that extends no more than 1.5 times theeffective diameter from the distal opening 608 measured along theopening axis. The restrictor 610 has an area when viewed along theopening axis OA that can be 0.1 to 1.2 times the area of the distalopening 608 when viewed along the opening axis OA. Thus, the restrictor610 may be somewhat small when less concerned with moving, gathering orclearing material from the opening 608.

The support arm 612 may have an angular extent B when viewed along theopening axis OA of no more than 90 degrees as shown in FIG. 7. Thedistal opening 608 may be free of obstruction apart from the support arm612 between the distal opening 608 and a stop 614 on the restrictor 610when viewed along the opening axis OA. The restrictor 610 forms a feedopening 622 leading to the distal opening 608 when the restrictor 610 isin the working position shown by the dotted-line position of FIG. 6B.The feed opening 622 defines a surface 626 extending between and definedby the restrictor 610 and a distal end of the shaft 623 around theopening 608. The surface 626 may be an elongate surface that,essentially, extends from one side of the support arm 612 to the other.In this manner, an average length of the surface 626 is 2.5-3.5 timesthe effective diameter. The surface 626 may have a width of 0.8 to 1.1times the effective diameter.

The support arm 612 may be longitudinally and/or rotatably movablerelative to the shaft 602 to adjust a longitudinal or rotationalposition of the support arm 612 as shown in the dotted-line and solidline positions. The support arm 612 is movable from a working position(as defined above) to a displaced position with the working positionbeing a position used when suctioning material into the distal opening608. The shaft 602 has a longitudinal axis LA and the restrictor 610 isformed with the support arm 612 rotating and/or longitudinallydisplaceable. The restrictor 610 may be formed so that the displacedposition moves material toward the distal opening 608. The restrictor610 may also be extended outwardly to help gather or otherwise organizematerial to be suctioned. The restrictor 610 may be movable to aposition that is at least two effective diameters from the distalopening 608 measured along the opening axis OA.

The restrictor 610 can be mounted over the shaft, for example, in aconcentric manner although an interlocking or independent lumens areconsidered herein so long as the restrictor 610 is over the shaft andoutside the lumen in some embodiments. The restrictor 610 is movable toa stored position in that the entire restrictor 610 is positionedproximal to the distal opening 608 and optionally completely outside thelumen 604 as shown in the dotted-line position of FIG. 6A. Thus, theuser may elect to use the suction device without restriction, forexample, when the likelihood of clogging the opening is low. Therestrictor 610 may be deformed when in the stored position and, to thisend, the restrictor 610 has a living hinge 640 with the support arm 612forming part, or all, of the living hinge 640 that is deformed in thestored position.

The stop 614 may be part of the support arm 612 in that the distal endof the support arm 612 simply forms the stop 614. Furthermore, therestrictor 610 may also simply be part of an extension of the shaft.Finally, the restrictor 610 and methods associated with the restrictor610 may be used with any of the other devices described herein includingthose associated with cutting and/or removing the lens. Furthermore, thedevices may be used through the lumen of any of the devices describedherein by simply providing a y-arm 642 and a suitable connector 641 thatforms a seal around the cutting device. Thus, the lumen may be asubstitute for any lumen described herein and the method of cutting thelens in combination and aspirating material and the device combinationincluding any lens cutting device coupled with any aspirating devicebeing specifically incorporated herein. For example, referring to FIGS.6B and 6C, a seal is provided at the Y-arm 642 in the lumen and suctionpath through which any of the cutting devices described herein (oranother cutting device) may be introduced. FIG. 6B shows the sealcentrally located rather than on a Y-arm so the cutting device extendsdirectly through the lumen with suction in the annular space between thecutting device and the shaft. Furthermore, an irrigation lumen, whichmay be concentric or separate, may be provided and the process ofirrigating may be practiced with any method or combination methoddescribed herein and such methods are specifically incorporated here asshown in one or more embodiments and expressly incorporated into thosethat do not.

In use, the distal end of the shaft is positioned in the eye for anyprocedure on the eye including cataract surgery. During cataract surgerypieces of the cataract are removed using suction. Material can besuctioned into the distal opening by applying suction that drawsmaterial into the distal opening. The restrictor 610 may help to reduceclogging of the distal opening compared to conventional suction devicesthat permit unrestricted flow toward the distal opening. As mentionedabove, a problem with the conventional method is that material that islarger than the suction opening is free to approach and, thus, clog theopening. Suction must be stopped and, if necessary, the material removedindependently by another instrument. Described herein are devices thatreduce the likelihood of clogging whether by providing the restrictor orother mechanisms as will be described in more detail below. It should beappreciated that devices described herein can be used with any deviceincluding a stand-alone aspiration device, a re-usable phacoemulsiontip, or a disposable aspect of any aspiration device.

In another aspect, tissue manipulators and method of manipulating tissueare described. The tissue manipulator can be positioned on a separatesurgical device or a surgical device incorporating suction as describedelsewhere herein. FIGS. 8A-8C illustrate an implementation of a tissuemanipulator 660 having a shaft 662 with a lumen 664 and a distal opening668. A source of suction may be coupled to the lumen 664 with suctionbeing used together with or separately from the tissue manipulator 660.Irrigation may also be supplied with the other shafts incorporatedherein and such incorporation is expressly provided here. The tissuemanipulator 660 can include a plurality of loops. In someimplementations, a first loop 670 has a first leg 672 and a second leg674 with at least one of the first and second legs 672, 674 extendingthrough the lumen 664. The first loop 670 is movable from a collapsedposition of FIG. 8A to an expanded position of FIG. 8B when the firstand second legs 672, 674 are advanced through the lumen 664 and out thedistal opening 668. A second loop 676 can also have a first leg 678 anda second leg 680 with the first and second legs 678, 680 extendingthrough the lumen 664. The second loop 676 is also movable from acollapsed position to an expanded position when the first and secondlegs are advanced through the lumen and out the distal opening 668. Theshaft 662 may be sized for introduction of a distal end of the shaftinto an eye.

The first loop 670 may have an unbiased shape that bounds an areadefined in an orientation OR that maximizes the area. The area has aneffective diameter that is equal to the diameter of a circle having thesame area. The first loop 670 moves toward the unbiased shape whenmoving from the collapsed position to the expanded position. Theeffective diameter of the area of the first loop 670 can be 4.5 mm to6.5 mm or can be 5.0 mm to 6.0 mm. The effective diameter of theunbiased shape of the first and/or second loops 670, 676 may be within20% of an effective diameter of the expanded position of the firstand/or second loops 670, 676, respectively. In this manner, the firstand/or second loops 670, 676 provide for a soft deployment and areflexible during use. Use of a superelastic material further enhances theflexibility of the first and second loops 670, 676. To this end, thefirst and second loops 670, 676 may be formed of superelastic wirehaving a diameter of about 0.003″ to about 0.006″ although any size maybe used with any suitable cross-sectional shape.

The first and second loops 670, 676 are each defined by the orientationOA that maximizes an area of the first loop 670 and second loop 676 whenin the expanded position when viewed along each orientation. Theorientation of the first and/or second loop 670, 676 may be within 45degrees of perpendicular to the longitudinal axis LA at a distal end ofthe shaft 662. The first loop 670 can be spaced apart from the secondloop 676 to define a volume V therebetween when the first and secondloops 670, 676 are in the expanded position with the volume therebetweenbeing 48-84 mm³. As will be described in more detail below, theplurality of loops of the tissue manipulator 660 can be spaced apartfrom one another during expansion of the loops or in a separate stepfollowing expansion of the loops.

The tissue manipulator 660 may also include an intermediate element orthird loop 682 positioned between the first loop 670 and the second loop676. The intermediate element 682 may include an interconnecting element681 extending between the first loop 670 and the second loop 676. Theinterconnecting element 681 may be integrally formed elements with thefirst loop 670 and the second loop 676 as shown in FIGS. 9 and 10.Alternatively, the interconnecting element 681 may be a flexiblefilament extending between the first loop 670 and the second loop 676 asshown in FIG. 8B. The third loop 682 may have the features of the first670 and second loops 676. The orientation OA that maximizes an area ofthe third loop 682 may be within 30 degrees of perpendicular to thelongitudinal axis LA.

The first and second loops 670, 676 provide a controlled amount ofexposed surface therebetween to control, and optionally cut, acontrolled amount of the material. The exposed surface ES between thefirst loop 670 and the second loop 676 has an area of 15 mm² to 60 mm².Stated another way, the exposed surface between the first loop 670 andthe second loop 676 is 3-10 times the effective diameter in the expandedposition (or the unbiased position since they may be the same).

The exposed surface between the first loop 670 and the second loop 676may have 2-8, 2-6, 2-4 or even just 2 independent cells when viewed in aradially inward direction relative to the orientation axis of the firstand second loops 670, 676. The exposed surface ES has an area that is atleast 4 times larger than an area of the intermediate element 682positioned between the first loop 670 and the second loop 676 when theexposed surface ES is viewed radially inward with respect to the firstand second loops 670, 676. In this manner, the intermediate element 682does not take up an excessive amount of room as compared to somenet-type devices.

The first loop 670 may also be formed so that at least 80% of the loopis 1.5-3.5 mm from the second loop 676. The first and second loops 670,676 (and optional intermediate element 682) may also be configured tocut material contained within therein when collapsed.

Again with respect to FIG. 8B, the device 660 may include a firstsupport element 690 extending from a distal end of the shaft when thefirst loop 670 is in the expanded position. The first support element690 may be an elongate element that extends to a free end 691. The firstsupport element 690 is positioned with the free end 691 positionedwithin an area of the first loop 670 when viewing the first loop alongthe orientation OA that maximizes the area of the first loop 670. Thefirst loop 670 has an effective diameter when in the expanded positionwhile the first support element 690 extends into the area of the firstloop 670 so that the free end 691 is positioned 0.05 to 0.30 times theeffective diameter of the first loop 670 within the first loop 670 whenviewed along the orientation OA. A second support element 692cooperating with the second loop 676 in the same manner may also beprovided.

Referring to FIG. 11, the first loop 670 and/or second loop 676 may haveat least one interconnecting element 695 extending from a firstconnection 696 on the loop to a second connection 697 on the same loopor the loop(s) may be substantially free of any such interconnectingelements depending upon the desired use. For example, a net-likematerial as shown in FIG. 11 may be provided or the loops may be free ofinterconnecting elements so that the open area is free. All discussionand limitation of the first loop 670 are applicable to the first loop670, the second loop 676 and the third loop 682 as well as discussion ofthe first support 690 applicable to the second support 692. The firstsupport 690 may extend independently or simultaneously with the firstloop 670. The first support 690 helps to secure material within thefirst loop 670 by extending into the opening area formed by the loop.

The first and second legs of the first and second loop(s) may be movablewithin the lumen. Alternatively, the first leg 672 and the second leg674 of the first loop 670 are coupled to an actuator extending throughthe lumen so that movement of the actuator moves the first leg 672 andthe second leg 674 between the collapsed position and the expandedposition. The first leg 678 and the second leg 680 of the second loop676 are coupled to an actuator extending through the lumen so thatmovement of the actuator moves the first leg 678 and the second leg 680between the collapsed position and the expanded position. The first loop670 and/or the second loop 676 may be positioned entirely distal to thedistal opening in the expanded position. The first loop 670 and thesecond loop 676 may include a superelastic material within asuperelastic range when in the collapsed position.

Referring to FIG. 12, a tissue manipulator 700 can have a concaveelement 702 coupled to a first loop 704 to form a basket 706 to receivematerial. The concave element 702 may have one end 708 integrally formedwith the first loop 704 with the other end 710 movable within a lumen712 of a shaft 713 independent of a first leg 714 and a second leg 716of the first loop 704. Cross-elements 715 are also integrally formedwith the first loop 704 and may also be integrally formed with theconcave element 702. Alternatively, both ends 708, 710 may be integrallyformed with the loop 704.

Another tissue manipulator 700A is shown in FIG. 13 wherein the samereference numbers refer to the same or similar structure. A concaveelement 702A, which may be 2-3 concave elements 702A. The manipulator700A has a first loop 704A with a first leg 714A and second leg 716A. Afirst end 708 a of the concave element 702A may be integrally formedwith the loop 704A while the second end 710A may be independentlymovable within a lumen 712A. The loop 704A and the concave element 702Amay be made of ribbon-shaped material having a width to thickness ratioof more than 3 to 1 to create a more closed basket 706A compared to wirehaving a 1 to 1 ratio. Referring to FIG. 14, another tissue manipulator700B is shown wherein the same or similar reference number refer to thesame or similar structure. The manipulator 700B has a first loop 704Bwith a concave element 702B being a net 703. The net 703 may beintegrally formed or a separate element attached to the loop 704B.

Referring to FIG. 15, another tissue manipulator 700C is shown whereinthe same or similar reference number refer to the same or similarstructure. The manipulator 700C has a first loop 704C with a concaveelement 702C, which may be 2-3 concave elements 702C, integrally formedat first end 708C and may have a second end 710C independently movablewithin a lumen 712C within shaft 713C or a separate element attached tothe loop 704C. The manipulator 700C is free of interconnecting elementsbetween any two sides of the loop and may also include nointerconnecting elements between the concave elements 702C.

Referring to FIGS. 16 and 17, another tissue manipulator 700D is shownin FIG. 16 wherein the same reference numbers refer to the same orsimilar structure. The tissue manipulator 700D has a first loop 708D anda second loop 708E with corresponding concave elements 702D and 702E,respectively. A first basket 706D and a second basket 706E are movablebetween a nested position of FIG. 17 and a position in which the twobaskets oppose one another as shown in FIG. 16.

Referring again with respect to FIG. 12, the tissue manipulator 700 isdescribed further and it is understood that all aspects described hereare applicable to all of the other tissue manipulators 700A-700D and areexpressly incorporated for each. The loop 704 has an unbiased shape thatbounds an area defined in an orientation OA that maximizes the area. Thearea has an effective diameter that is equal to the diameter of a circlehaving the same area. The first loop 704 moves toward the unbiased shapewhen moving from the collapsed position to the expanded position. Thefirst loop 704 may have effective diameter of 4.5 mm to 6.5 mm or 5.0 mmto 6.0 mm. It should be appreciated that other sized are consideredherein. As used herein, the “area” of the loop is determined by theorientation OA that maximizes the area. The first loop is expanded withthe first loop orientation being within 45 degrees of perpendicular to alongitudinal axis LA at a distal end of the shaft 713.

Referring again to FIG. 13, a rotating cutter 740 is shown that may beused with any of the device and methods described herein. The rotatingcutter 740 has a cutting element 742 at a distal end 744 that may be aseries of teeth 746, a sharpened edge, ridges spikes or any othersuitable shape. Rotating as used herein may mean rotation in onedirection and then back in the other without departing from the scope ofthe invention. The rotating cutter 740 may be independently positionedand moved for use as desired or may be fixed in a working position shownby dotted-line working position 750. The rotating cutter 740 can berecessed from the distal end 751 of the shaft 713A when in the workingposition 750 so that the rotating cutter 740 is not exposed from anopening 754 at the distal end of the shaft 713A. The tissue manipulatingdevices described herein may be used to push, draw, squeeze or otherwisemanipulate tissue into engagement with the rotating cutter 740. Therotating cutter 740 may further have a suction lumen 752 therein forsuctioning material.

Referring now to FIGS. 18A-18D and FIG. 19, a cutting device 800 forcutting material in the eye and, in a specific application, for cuttinga whole lens while contained within a capsular bag is shown. The cuttingdevice 800 has a shaft 802 with a first shaft part 804 and a secondshaft part 806 that are movable relative to one another between a firstposition of FIG. 18A and a second position of FIG. 19. An elongateelement 808 has a first end 810 coupled to the first shaft part 804 anda second end 812 coupled to the second shaft part 806. The cuttingdevice 800 forms a loop 814 with at least part of the elongate element808 forming the loop 814 together with the shaft 802. The loop 814 movesfrom a collapsed position of FIG. 18A to an expanded position of FIG. 19when the first and second shaft parts 804, 806 move from the firstposition to the second position. The loop 814 may be expanded to advancethe loop 814 between the capsular bag and the whole lens. Material ispositioned in an open area 813 of the loop 814 and then cut bycollapsing the loop 804.

The elongate element 808 expands in a manner that facilitates cuttingthe whole lens within the capsular bag. The elongate element 808 mayhave a first flexible portion 820 and optionally a second flexibleportion 822 with an intermediate portion 824 therebetween. The elongateelement 808 initially expands laterally outward as shown in FIG. 18C.When the first and second flexible portions 820, 822 begin to bend, theloop 814 has a proximal portion 826 and a distal portion 828 that extendproximally and distally, respectively, from the intermediate portion824. The flexible portion may be at least 1.5× stiffer in bending thanthe intermediate portion 824. Furthermore, the elongate element 808 maybe in an unbiased position when collapsed as shown in FIG. 18A with theelongate element 808 being deformed to deflect and expand the loop. Theelongate element 808 may also have a preset shape that facilitatesmovement to the expanded position while requiring less force to deformthe elongate element 808.

Referring now to FIGS. 20A-20C and FIGS. 21A-21B, another cutting device900 is shown for cutting material in the eye and, in a specificapplication, for cutting a whole lens WL within a capsular bag CBthrough an opening OP (such as a capsulorhexis) that exposes an anteriorsurface of the lens (see FIG. 19). A shaft 902 has a first shaft part904 and a second shaft part 906 movable relative to one another betweenthe position of FIG. 20A and FIG. 20B so that a loop 908 formed by thedevice 900 moves from a collapsed position to an expanded position. Anelongate element 910 has a first end 912 coupled to the first shaft part904 and a second end 914 coupled to the second shaft part 906. The loop908 is formed at least in part by the elongate element 910 with the loop908 also being formed by a portion of the shaft 902.

The loop 908 is expanded so that the first end 912 has a longitudinalorientation LFE that changes by an angle CA at least 120 degrees withrespect to the shaft 902 adjacent to the second end 914 of the elongateelement 910 when the first and second shaft parts 904, 906 move from thefirst position to the second position. FIG. 21A shows the angle CA beingabout 180 degrees.

The 902 shaft may also include a flexible distal end 920 with the firstend 912 of the elongate element 910 coupled to the flexible distal end920 of the shaft 902. The flexible distal end 920 of the shaft 902 maycontribute to the changing orientation of the first end 912 with respectto the longitudinal orientation of the shaft 902 adjacent the second end914. The flexible distal end 920 may change in orientation by an angleCO of at least 30 degrees when the first and second shaft parts movefrom the first position to the second position.

The first end 912 of the elongate element 910 may be have a pinnedconnection so that the first end 912 rotates relative to the first shaftpart 904 for an angle of at least 120 degrees and may be for 180degrees+/−45 degrees when the first and second shaft parts move from thefirst position to the second position. The loop 908 has a distal portion930 that advances distally beyond a distal end of the shaft 902 as theloop 908 moves from the collapsed position to the expanded position. Thefirst end 912 of the elongate element changes orientation so that theloop 908 advances distally beyond a distal end of the shaft 902 as theloop 908 moves from the collapsed position to the expanded position. Thesecond end 914 may also have a rotatable connection 932, such as apinned connection 934, to the second shaft part 906. The second end 914may rotate and change in orientation relative to the shaft adjacent thesecond end by 90 degrees+/−45 degrees when the first and second shaftparts 904, 906 move from the first position to the second position. Theelongate element 912 may be in an unbiased position in FIG. 20A with theelongate element 912 deformed into the positions of FIG. 21A and FIG.21B. Of course, the elongate element 912 may also have a preset shapesimilar to FIG. 21B.

Referring to FIGS. 22A, 22B, 23A, and 23B, another device 940 is shownfor aspirating material from the eye. As will be described in moredetail below, the device 940 is configured to apply pulsed vacuum andoptionally pulsed vacuum with a short regurgitation in between pulses.This pulsed vacuum configuration allows for full vacuum pressure to beapplied through larger aspiration lumen diameters without causinganterior chamber collapse. Thus, full vacuum can be applied, but thevacuum is applied in short pulses, for example, by valving. All methodsand physical characteristics of the other aspiration devices describedherein are equally applicable to the device 940 and all such uses andcharacteristics are expressly incorporated here. For example, the volumeof the suction path, the size of the lumen and the distal suction volumeand methods of use are all expressly incorporated here.

The device 940 may include a hand-held unit 960 having an elongate shaft961 coupled to and extending from a housing 962 of the hand-held unit960. A lumen 963 extends through the shaft 961 to an opening 964 at adistal end 965. The lumen 963 defines part of a suction path 966extending from a suction source to the opening 964. The suction path 966defines a suction volume under the influence of the suction pressure bythe suction source and a distal suction volume 967. The suction sourcecan be within, on, or attached to the hand-held unit 960.

The device 940 has a valve 968 coupled to the hand-held unit 960 andpositioned along the suction path 966. The valve 968 is movable from aclosed position of FIG. 22A, which blocks the suction path 966, to afully open position, which defines a largest suction path provided bythe valve 968. FIG. 22B shows the valve partially open. The valve 968may also be positioned in any position between the closed and fully openpositions as described below. The valve 968 is movable relative to anaperture 970 that is opened and closed by the valve 968 to open andclose the suction path 966. The valve 968 can be a movable element 971coupled to a wire 972 that is used to move and position the valve 968. Aspring 973 acts on the valve 968 to bias the valve 968 closed.

The wire 972 can be coupled to an actuator 942 shown in FIGS. 23A and23B that is configured to displace and position the valve 968. Theactuator 942 may include a foot pedal 944 for use as described below.Any other suitable actuator 942 may be used as well. For example, theactuator 942 can be positioned on the hand-held unit 960 or the actuatorcan be remote from the hand-held unit 960. The foot pedal 944 can be inan off or resting position in that no suction is supplied as shown inFIG. 23A. The foot pedal 944 has a first pivot 945 that is coupled tosupport mounted to a base 947. The foot pedal 944 has a second pivot 948that is located near first end 949 of a linkage 950 and may also includea dampener (not shown) to dampen motion of the foot pedal 944. A secondend 951 of the linkage 950 has a pivot 939 and may include a sensor 941that indicates the position of the foot pedal 944. As the foot pedal 944is depressed, the amount of displacement may be measured in any suitablemanner such as the rotational position sensor 941. The second end 951 ofthe linkage 950 can be attached to a support sled 946 that is slideablerelative to the base 947.

The actuator 942 can have a motor 956 that drives a connecting arm 957coupled to a slider 958. The slider 958 is coupled to the wire 972 (seeFIGS. 23A and 23B) so that control of the motor 956 controls theposition of the valve 968. The actuator 942 is also coupled to thesource of vacuum 974, which may be any suitable source, for example, thesuction source may include a pump, a venturi, or may be a syringe with aspring-loaded plunger as described elsewhere herein. The suction sourcecan be within the hand-held portion as described elsewhere herein orremote from the hand-held portion. The actuator 942 controls themagnitude of suction in any suitable manner and as described elsewhereherein. The valve 968 is movable to a partially open position betweenthe closed position and the fully open position and may be positioned atany position therebetween. The partially open position can have across-sectional flow area that is 5-15% of a cross-sectional flow areaof the fully open position. As used herein, the percentage open isgenerally proportional to the longitudinal position of the valve 968relative to the aperture 970. The partially open position may also be anopen position that is less than 15% of the cross-sectional flow area ofthe fully open position.

The support sled 946 is slideably mounted to the base 947 to displacelaterally when the foot pedal 944 is displaced. The support sled 946also carries the motor 956. The vacuum source 974 is independentlymounted to the base 947 so that the wire 972 may move independent of thelumen (not shown) coupled to the connector. A control system 991 iscoupled to the motor 956 and vacuum source 974 to control each of thesecomponents as described herein.

The actuator 942 is operably coupled to the valve 968 and the suctionsource 974 and may be operated in any conventional manner. For example,the valve 968 may move between a first position and a second positionthat exposes more of the aperture 970 to increase and decrease thesuction pressure periodically.

In accordance with another aspect, the actuator 942 may also control thevalve 968 and suction source 974 as now described. When the actuator 942is initially displaced from the position of FIG. 23A, the actuator 942moves the valve 968 to the partially open position during a first phaseof displacement of the actuator 942 from the off position. During thefirst phase, the vacuum source 974 increases the vacuum/suction pressureas the actuator 942 displacement increases. The valve 968 may stay inthe partially open position until the vacuum pressure reaches at least75% of a target maximum pressure that may be 570 mmHg (with a targetpressure of 760 mmHg). The first phase may also continue until thetarget pressure is reached. Stated another way, the actuator 942controls the valve 968 to being no more than half open until the targetpressure is reached during the first phase of displacement of theactuator 942. The target pressure may also simply be reached byincreasing the suction pressure without modulating the pressure untilfull suction pressure is reached without regard to the actual pressureas long as the result is reaching the target pressure in the mannerdescribed herein.

Once the target pressure has been reached, further displacement of theactuator 942 (e.g. foot pedal 944) defines a second phase ofdisplacement in that the suction pressure is increased and decreased ata rate of at least 1 Hz (or 1-10 Hz). During the second phase, the valve968 moves between a first position and a second position with the secondposition providing a larger cross-sectional flow area along the flowpath than the first position. The first position may be the partiallyopen position or may be the closed position and, similarly, the secondposition may be the fully open position or any other intermediateposition so long as it provides a larger flow area than the firstposition. When the valve 968 is open in the first position, thecross-sectional flow area in the first position may be at least 5%, or5-15%, of the cross sectional flow area related to the fully openposition of the valve 968. The first and second phases may provide animprovement over some systems and methods that immediatelymodulate/cycle the suction pressure. The first phase may help inestablishing the desired suction pressure that is then transitioned tothe cyclic/periodic or modulated second phase.

The actuator 942 may also have a third phase of displacement followingthe second phase (or directly after the first phase). During the thirdphase, the actuator 942 also moves the valve 968 between a firstposition and a second position with the second position of the valve 968providing a larger cross-sectional flow area along the flow path thanthe first position. The third phase of operation moves the valve betweena first position and a second position with the second position having alarger cross sectional flow area than the first position, As theactuator 942 displacement is increased, the duty cycle increases so thatthe valve 968 increases time nearer to the second position relative tothe first position. The valve 968 is preferably moved at a rate of atleast 1 Hz during this phase of operation.

Alternatively, the actuator 942 is operably coupled to the valve 968 sothat an increase in displacement of the actuator 942 during the thirdphase causes the second position of the valve 968 to define anincreasing cross-sectional flow area for the suction path (such as anincreasing amount of the aperture being exposed, for example). The firstposition may stay the same during the third phase and may be thepartially open position. Stated another way, during the third phase, theactuator 942 is operably coupled to the valve 968 so that the increasein displacement of the actuator 942 (foot pedal 944) increases adistance between the first position and the second position so that moreof the aperture is exposed during each cycle. During the second andthird phases the vacuum source may be maintained at full suctionpressure. As used herein, the terms “first”, “second” and “third” may beinterchanged and, in particular, in the claims. For example, the claimsmay be formed to recite the just described first and third phases as thefirst and second when the just described second phase is omitted.Furthermore, the second phase may form part of the third phase in thatthe second phase is established when the third phase is initiated.

The valve 968 may also be movable along the suction path to purge thesuction path by moving material through the suction path in an oppositedirection to suction of material. To this end, the valve 968 is movabledistally beyond the closed position so that the valve 968 pushesmaterial in the direction opposite to suction, that is, distally throughthe suction path toward the opening 964. The valve 968 may displacematerial in the opposite direction to suction during each cycle ofmovement (from the first position to the second position and back to thefirst position). The material in the suction path is purged in thismanner that may help dislodge material caught in the suction path orstuck to the tip. The valve 968 displacement is limited by a stop 975that defines the volume displaced by the valve 968.

Referring to FIGS. 24A-24B, another device 940A is shown that has anadjustable stop 975A that adjusts the maximum displacement of the valve968A and, thus, adjusts the volume that is displaced by the valve 968A.The adjustable stop 975A is coupled to a thumb screw 976 that ismanually operable by the user to adjust the position of the adjustablestop 975A. The stop 975A is positioned in a cavity 977 in the valve 968Aand limits the motion of the valve 968A when the valve 968A contacts thestop 975A. Referring to FIGS. 25A-25B, another device 940B is shownhaving an adjustable stop 975B coupled to a cam 978 that engages thevalve 968B. The cam 978 is rotated by the user with a dial 986 to adjustthe maximum displacement of the valve 968B and volume of the displacedmaterial.

The adjustable stops 975A, 975B also provide on-demand purge capability.For example, the stops 975A, 975B may be initially positioned so thatthe maximum distal displacement corresponds to the closed valveposition. When retrograde purging is desired, for example, to dislodgematerial in the lumen or stuck to the distal end, the stops 975A, 975Bcan be moved to a position that permits distal travel beyond the closedposition. When the valve 968 travels distally beyond the closedposition, the valve 968 seals with the suction path along O-rings 979 sothat the valve 968 acts like a positive displacement pump when movingmaterial in the opposite direction to suction (i.e. towards the distalopening). The valve 968 also draws material in the direction of suction(after moving material in the opposite direction) so that the valve 968acts like a positive displacement pump in the direction of suction,which may aid in reestablishing suction flow during the flow reversal asthe aperture 970 is opened.

Still another device 940C for aspirating material in the eye is shown inFIG. 26. The device 940C includes a retrograde flow channel 980 fluidlycoupled to a lumen 981 and a retrograde flow element 982 is configuredto move the fluid through the retrograde flow channel 980 into the lumen981 in the opposite direction to clear the lumen 981 and material stuckto a distal end. The retrograde element 982 may be a plunger/piston 983,bladder or any other suitable mechanism for moving fluid. The piston 983is coupled to a thumb actuator 984 although any other suitable actuatormay be used. The adjustable stops 975A, 975B of the devices of FIGS.24A-24B and 25A-25B and the retrograde flow channel 980 and retrogradeflow element 982 of FIG. 26 may be incorporated into the device 940 ofFIGS. 22 and 23 (or any other suitable devices described herein) andsuch combinations shall include all uses, methods and characteristics ofthe other devices are applicable to the combination and expresslyincorporated herein.

Described herein are various devices configured to perform one or morefunctions useful in ophthalmic procedures including, but not limited to,cutting, fragmentation, emulsification, aspiration, and/or inspirationof material present at a target location during a procedure in the eye.“Material” as used herein can include fluids (from the eye or providedto the eye), tissues, or fragments of tissues such as lenticular tissue,vitreous tissue, cells, and any other fluid or tissue or other materialthat may be present during a procedure in the eye (e.g. cataractprocedure, vitrectomy procedures, and the like). The devices describedherein configured to apply vacuum may also be configured to deliverfluids. The devices described herein that apply vacuum and/or deliverfluids may also be configured to cut, fragment, emulsify, or otherwisemake smaller material in and near the surgical site. Devices describedherein that allow for vacuum to be applied can provide that vacuum usingpulsed vacuum with or without interspersed pulsed positive pressure.

The various features and functions of the devices described herein maybe applied to one or more devices described herein even though they maynot be expressly described in combination. It should also be appreciatedthat various features and functions of the devices described herein canbe applied to conventional devices and systems known in the art alsouseful for cutting, fragmenting, emulsifying, or otherwise impactingtissues at or near a surgical site, including, but not limited tophacoemulsification systems, vitrectomy systems, and other tools usefulin performing cataract surgeries or vitrectomy surgery, and the like.

FIGS. 27A-27H and FIGS. 28A-28N illustrate interrelated implementationsof devices configured to cut and aspirate material during procedures inthe eye. The devices allow for performing cataract surgeries in aminimally-invasive, ab interno approach through clear corneal incisions.The devices described herein rely on fewer manipulations and less energyto remove the lens from the eye. The devices are configured to createsmaller lens fragments with a single cut that are easier to removethrough the small incisions with little to no phacoemulsification. Thedevices described herein can be all-in-one devices configured to cut alens in situ into small lens fragments that can be removed by the samedevice with aspiration and little to no phacoemulsification.

FIGS. 27A-27H illustrate a device 2700 that includes a hand-held unit2760 having a distal, elongate member or shaft 2761 coupled to andextending longitudinally from a housing 2762 of the hand-held unit 2760.At least a distal end region of the shaft 2761 is configured to beinserted into the eye in a minimally-invasive manner to cut, aspirate,and/or inject material in the eye, such as during a cataract procedure.The shaft 2761 can be an elongate member configured to oscillate.

As used herein, “oscillate” or “oscillating movements” can include anyperiodic, repetitive movement that occurs according to a pattern andneed not be sinusoidal. The oscillating movement can includereciprocating sliding movements that occur in a back and forth mannerrelative to the hand-held unit. The oscillating movement can includerepeatedly advancing and retracting the elongate member along itslongitudinal axis. The repeated advancing and retracting may occur alongthe longitudinal axis, but the path the oscillating movements take neednot be linear. The path of movement can occur non-linearly (i.e. awayfrom the longitudinal axis during at least a portion of the movement)along an elliptical pathway or a curvilinear pathway. The path ofmovement can be rotationally, orbitally, torsionally around thelongitudinal axis of the device or other type of movement relative tothe longitudinal axis of the device including three-dimensionalmovements in which the elongate member moves back and forth as well asfrom side-to-side. The oscillating movements include profiles ofrepetitive movement patterns that may change depending on where in thecycle of oscillation the movement occurs. The oscillating movements canbe asymmetric in profile, as will be described in more detail below.

Any of a variety of configurations of the elongate member are consideredherein. In some implementations, the elongate member can include atubular oscillating elongate member having an internal lumen extendingthrough it such that fluids can be delivered and/or aspirated throughthe oscillating elongate member. In other implementations, theoscillating elongate member is not tubular, but instead formed as asolid element. In this implementation, the oscillating elongate membercan reciprocate within an outer tubular member and a gap between theshafts sized to receive and/or deliver fluids to the treatment site.Where the elongate member is described as having inner and outer membersthe elongate member can also be formed of a single tubular elementconfigured to oscillate relative to the hand-held unit to cut andaspirate material. Where the elongate member is described as having aninner elongate member coaxially arranged within an outer tubular memberthe inner elongate member can be a solid rod and need not include aninner lumen. In some implementations, the elongate member has asharpened cutting tip or bevel, which can include a needle tip.

Use of the term “needle” or “needle tip” need not imply the elongatemember has a lumen extending through it as a syringe needle would. Forexample, an elongate member having a sharpened needle tip can be a solidelement extending through an outer tubular member and aspiration forcesapplied through the lumen of the outer tubular member such that fluidsand tissues are drawn into an annular gap extending between the innerand outer members. In other implementations, the elongate member is acutting tube having an inner lumen and distal edge configured to cuttissue. The distal edge can be sharpened while the opening into the tubecan be cut at an angle to the elongate axis of the elongate member orperpendicular to the elongate axis of the elongate member. The cuttingtube can have an inner lumen configured to aspirate materialtherethrough, such as ocular lens material, lens fragments, and/orfluids from the eye. Thus, aspiration forces can be applied through theinner lumen of the inner elongate member. However, aspiration forces canalso be applied through a lumen of a tubular outer member. The gapbetween the tubular outer member and the inner member can vary, forexample, between about 0.001″ to about 0.100″. In some implementations,the aspiration forces can be applied through both the inner elongatemember having a lumen and the lumen through the outer tubular member.

Again with respect to FIGS. 27A-27H, the shaft 2761 can be avitrectomy-style cutting element in that it can have an elongate member2755 extending through and coaxially arranged within an outer tube 2759such that the elongate member 2755 slides reciprocally within the outertube 2759. This style cutting element can be particularly useful forchopping and removing harder lens material compared to tips such asthose shown in FIGS. 6A-6C described above. The outer tube 2759 can be astationary tubular element coupled to a distal end region of the housing2762. The outer tube 2759 can be fixedly coupled within an interior ofthe distal end region of the housing 2762 by a retainer 2743. Theretainer 2743 can be a donut-shaped element configured to receive theouter tube 2759 therethrough such that the retainer is positioned abouta proximal end region of the outer tube 2759. The elongate member 2755can also be a tubular element, but unlike the outer tube 2759, ismovable such that it can be oscillated within the lumen of the outertube 2759. A distal tip of the elongate member 2755 can be formed into acutting edge 2754. In some implementations, the cutting edge 2754 is ashort, sharpened bevel (see FIG. 27C-27D). Each of the outer tube 2759and the elongate member 2755 can have an opening 2753, 2758 near theirrespective distal end regions. In some implementations, the openings2753, 2758 are formed through respective side walls (see FIGS. 27C-27D).Together, the cutting edge 2754 of the elongate member 2755 and theopening 2753 of the outer tube 2759 form a port 2764. The port 2764 canvary in size depending on the position of the elongate member 2755relative to the outer tube 2759. In operation, tissue may enter into theshaft 2761 through the port 2764 and be dissected by the cutting edge2754 as the elongate member 2755 is reciprocated within the outer tube2759.

The device 2700 can include a removable or retractable, outer sheath forsliding over the openings 2753, 2758, for example, during insertion ofthe shaft into the anterior chamber. During insertion, the cutting areaof the shaft can remain covered with the sheath to prevent snagging onthe incision or other eye tissues prior to cutting. After insertion, thesheath can be retracted or otherwise removed when the operator is readyto start cutting and/or aspirating. The retraction can be manuallyactivated by a user or can be automatically retracted by the device uponactuation of cutting and/or aspiration. After cutting/aspiration iscomplete and the instrument is ready to be removed from the eye, thesheath can be advanced distally to once again cover the openings 2753,2758.

The shaft 2761 is described above as including an oscillating elongatemember 2755 extending through an outer tube 2759. The outer tube 2759can be stationary and thereby protect the corneal incision or othertissues through which the shaft 2761 extends from being impacted byoscillating movements of the elongate member 2755. The shaft 2761 caninclude a single tubular elongate member 2755 that oscillates withoutany outer tube 2759. However, it is preferable the shaft 2761 include aprotective sheath surrounding at least a portion of the oscillatingelongate member 2755, for example, to protect the cornea from tissuedamage due to being exposed to the oscillating movements of the elongatemember 2755. The protective sheath can be formed of an elastic materialsuch as silicone or a more rigid metal hypotube. The protective sheathcan be exchangeable and/or retractable. The length of the protectivesheath can vary. The protective sheath can have a minimum lengthconfigured to cover the region where the shaft 2761 extends through thecorneal incision. The color of the sheath can provide informationregarding the length of the sheath and for what purpose it is useful. Auser can cover the oscillating elongate member 2755 and use a differentsort of tip during a procedure, for example for polishing or cleaning upafter cutting. Longer length of the protective sheath can cover half thestroke of the oscillation to be softer on the eye. The protective sheathcan also be useful to prevent clogging of the lumen of the shaft, forexample, by preventing tissues from ‘lollipopping’ the end of the shaft2761.

As will be described elsewhere herein, the shaft 2761 can also includean irrigation sleeve configured to deliver irrigation to the work site.The irrigation sleeve can extend over at least a portion of theprotective sheath. The irrigation sleeve and protective sheath can beremovable such that they detach from the hand-held unit 2760. In someimplementations, the irrigation sleeve and protective sheath are removedtogether as a single unit (e.g. as part of a removable cap) from thehousing or removed individually. Generally, the shaft 2761 (includingthe protective sheath and irrigation sleeve, if present) has a maximumcross-sectional diameter that is suitable for minimally-invasiveprocedures in the eye to minimize the corneal incision size. In someimplementations, the maximum cross-sectional diameter of the distalshaft 2761 is about 1.25 mm. The maximum cross-sectional diameter can besmaller than this or can be larger than this diameter, for example, nomore than about 2 mm in diameter, no more than about 3 mm in diameter,up to about 4 mm in diameter, or up to about 5 mm in diameter. Asdescribed elsewhere herein, a distal opening from the shaft 2761 canhave a smaller inner diameter in relation to the inner diameter of thelumen extending through the shaft 2761 to mitigate problems withclogging. In some implementations, the difference between the nominalinner diameter of the shaft 2761 and the inner diameter of the distalopening can be between about 0.003″ to about 0.006″. In someimplementations, the shaft 2761 can have a nominal inner diameter ofabout 0.0375″ that narrows at the distal opening to about 0.033″. Thus,eye tissue pieces that are less than the tip diameter can get aspiratedinto the lumen of the shaft 2761 and once inside the lumen are lesslikely to get stuck or cause a clog because the inner diameter of theremainder of the lumen is larger than the inner diameter of the distalopening.

The elongate member 2755 can be oscillated relative to the hand-heldportion by a drive mechanism operatively coupled to the elongate member2755. The drive mechanism can vary including electric, piezoelectric,electromagnetic, hydraulic, pneumatic, mechanic, or other type of drivemechanism known in the art. In some implementations, the elongate member2755 is reciprocated by a drive mechanism including a motor 2756contained within an interior of the housing 2762. The configuration ofthe motor 2756 can vary including, any of a variety of rotation motors,stepper motor, AC motor, DC motor, a piezoelectric motor, a voice coilmotor, or other motor.

In some implementations, the drive mechanism includes a motor 2756 suchas a gear motor having a gear head 2752 coupled (directly or via a motorcoupler 2789) to a proximal end of a rotating cam 2769. The rotating cam2769 can be coupled at an opposite end to a cam follower 2787, which isfixedly coupled to a proximal end of the elongate member 2755. The gearhead 2752 can be driven to rotate the rotating cam 2769, which convertsthe rotary motion of the motor 2756 into linear motion of the camfollower 2787 and thus, linear motion of the elongate member 2755.

In some implementations, as shown in FIGS. 27E-27H, the rotating cam2769 can be a generally cylindrical element having a bore 2789 in aproximal end configured to receive the gear head 2752. The cam follower2787 can have a bore 2790 in a proximal end configured to receive thedistal end of the rotating cam 2769. The rotating cam 2769 can be abarrel cam. The outer surface of the distal end of the cam 2769 has achannel 2792 configured to receive a corresponding pin element 2793 ofthe cam follower 2787. As the gear head 2752 turns the cam 2769 aroundthe longitudinal axis of the device, the pin element 2793 moves throughthe channel 2792 around the outside surface of the cam 2769. The channel2792 in the outer surface of the cam 2769 follows an elliptical pathfrom a first proximal end region towards a distal end region of the cam2769 and then from the distal end region back towards the first proximalend region. As the pin element 2793 moves through the channel 2792during rotation the cam follower 2787 is urged to move axially along alongitudinal axis of the device. The cam follower 2787 moves in a distaldirection for at least a fraction of the rotation. The cam follower 2787then moves in a proximal direction for at least another fraction of therotation. As such, a complete revolution of the cam 2769 providesreciprocating axial movement of the cam follower 2787 and the elongatemember 2755. It should be appreciated that other drive mechanisms tocreate oscillating movements of the elongate member are consideredherein.

Again with respect to FIGS. 27A-27D, the elongate member 2755 can becovered at least in part by the outer tube 2759. The outer tube 2759 maybe fixedly coupled to the housing 2762, for example, by the retainer2743. The oscillating elongate member 2755 can trap lens materialbetween cutting edge 2754 and the opening 2756 to cut small pieces ofthe lens material drawn into the port 2764. The port 2764 near a distalend 2765 of the shaft 2761 communicates with a lumen 2763 forming asuction path leading from the port 2764. The lumen 2763 forming thesuction path can extend through the elongate member 2755 and/or betweenthe elongate member 2755 and the outer tube 2759. In someimplementations, the lumen 2763 extends through the elongate member 2755to a proximal opening 2788. As best shown in FIG. 27B, the elongatemember 2755 can be coupled at a proximal end region to the cam follower2787. The elongate member 2755 extends through a vacuum manifold 2774located within the interior of the hand-held unit 2760 such that theproximal opening 2788 communicates with a chamber 2789 of the vacuummanifold 2774. The proximal opening 2788 is maintained within thischamber 2789 during oscillating movements of the elongate member 2755. Avacuum is applied within the vacuum manifold 2774 to aspirate thedissected tissue from the eye through the lumen 2763. The dissectedtissue enters the lumen 2763 at port 2764 and exits the lumen 2763through the proximal opening 2788. A plurality of seals 2794, such assliding O-rings that provide low resistance to movement, can preventand/or substantially reduce the passage of fluid around the shaft 2761.The device 2700 can be coupled to a suction source that is either remotefrom the hand-held unit 2760 or within an interior of the hand-held unit2760 such that the device 2700 is a fully hand-held device as describedelsewhere herein. Also, as described elsewhere herein, the elongatemember 2755 need not include an outer tube 2759 and can performfragmentation of tissues on its own. In some implementations, theelongate member 2755 can include a wall having a port 2764 through thewall where the port has a cutting surface. In other implementations, theelongate member 2755 can include a cutting tip such as a beveled cuttingtip. The cutting tip can include a distal opening from the lumenextending through the elongate member 2755. Ocular material can beaspirated through the lumen of the elongate member 2755, a lumen of theouter tube 2759, or both lumens.

The port 2764 can have a width that is optimized for fully chopping andaspirating the eye tissue. In some implementations, the port 2764 canhave an axial length that is greater than 0.05″ up to about 0.175″. Theport 2764 can have a width that can be between 0.015″ and 0.06″. Thewider port 2764 under full vacuum conditions (e.g. about 15 inHg up toabout inHg) can increase the risk of anterior chamber collapse. Thus, asdescribed elsewhere herein, the vacuum can be applied in pulses ofnegative pressure, for example, by actuation of one or more valves.Additionally, the cycles of negative pressure can be interspersed withshort regurgitation via application of positive pressure between pulsesof negative pressure. As described elsewhere herein, the cycling of thenegative pressure pulses and positive pressure pulses can be very fast(e.g. 1 Hz) and very small volumes (e.g. 5 cc).

As mentioned, the devices described herein can include one or more userinputs or actuators such as a button, slider, switch, or other input.The one or more user inputs can be on the device itself, remote from thedevice, or both. The device can include separate inputs to activate eachfunction of the device (i.e. aspiration, including pulsed vacuum withregurgitation between pulses, cutting, infusion, etc.). Alternatively,the input can be a multi-way button to activate more than a singlefunction of the device. For example, the device can be configured forvacuum and cutting. The one or more inputs can activate vacuum-onlyfunction and vacuum-plus-cutting function. Generally, cutting withoutvacuum is not desired, however, a cutting-only function is consideredherein as well. As an example and not to be limiting, a user canactivate a first button or place the button in a first position to turnon the vacuum-only function. After the first button is activated, theuser can then activate a second button or place the button in a secondposition to turn on the vacuum-plus-cutting function. The user can thencommence cutting while vacuum continues. In some implementations, thesecond button activation is only possible after the first buttonactivation occurs. In another implementation described in more detailbelow, the input can be a multi-way actuator that has a first positionconfigured to turn on both vacuum and oscillate the elongate member(i.e. vacuum-plus-cutting function) and a second position configured topause oscillation of the elongate member while the vacuum through theelongate member continues.

FIGS. 28A-28N illustrate a fully hand-held implementation of the device2700. The device 2700 includes a hand-held unit 2760 having a distalelongate member or shaft 2761 coupled to and extending longitudinallyfrom the housing 2762. The shaft 2761 can be an oscillating elongatemember configured to slide reciprocally relative to the hand-held unit2760. As described elsewhere herein, the shaft 2761 can be configured toundergo other types of movements including rotational, orbital, etc.Additionally, the oscillating elongate member can be tubular and have aninternal lumen extending through it such that fluids can be deliveredand/or aspirated through the oscillating elongate member. In otherimplementations, the oscillating elongate member is not tubular, butinstead formed as a solid element. In this implementation, theoscillating elongate member can reciprocate within an outer tubularmember and a gap between the shafts sized to receive and/or deliverfluids to the treatment site.

Again with respect to FIGS. 28A-28N, the shaft 2761 can be avitrectomy-style cutting element having an elongate member 2755extending through and coaxially arranged within the outer tube 2759 thatis operatively coupled to a drive mechanism configured to slide theelongate member 2755 in a reciprocating, oscillating fashion asdescribed above. The port 2764 near a distal end 2765 of the shaft 2761communicates with a lumen 2763 forming a suction path leading from theport 2764 towards the vacuum manifold 2774. The lumen 2763 can extendthrough the elongate member 2755 to a proximal opening 2788 of theelongate member 2755. In other implementations, the lumen 2763 canextend through the outer tube 2759 between the inner surface of theouter tube 2759 and the outer surface of the elongate member 2755 to aproximal opening 2788 from the lumen 2763. The proximal opening 2788communicates with a vacuum chamber 2703 of the vacuum manifold 2774. Avacuum can be applied within the vacuum manifold 2774 to aspirate thedissected tissue from the eye through the lumen 2763 such that materialfrom the lumen 2763 empties into the vacuum chamber 2703.

As mentioned above, the device 2700 can include a suction or vacuumsource that is found within an interior of the hand-held unit 2760. Thevacuum source can be a pump having any of a variety of configurations,including but not limited to bellows mechanism, diaphragm pump, venturipump, entrapment pump, positive displacement pump, regenerative pump,momentum transfer pump, micro pumps, or the like. The vacuum source neednot be limited to a piston pump and can incorporate any of a variety ofmechanisms configured to generate a negative pressure within the lumenof the elongate member.

As best shown in FIGS. 28E-28K, the vacuum manifold 2774 can be coupledto a piston manifold 2798 such that the vacuum chamber 2703 of thevacuum manifold 2774 is in fluid communication with one or more pumpingchambers 2705 in the piston manifold 2798. The piston manifold 2798houses pistons 2799 movable within the respective pumping chambers 2705that are powered by a drive mechanism such as a motor 2756 locatedwithin the proximal end of the device. The one or more pistons 2799powered by the motor 2756 generate a vacuum within the pumping chambers2705 as well as the vacuum chamber 2703 for aspiration of materialthrough the shaft 2761. In an implementation, the device 2700 caninclude one, two, or three, pistons 2799 movably positioned withinrespective pumping chambers 2705. It should be appreciated that anynumber of pistons 2799 can be positioned within respective pumpingchambers 2705. Multiple pistons 2799 bouncing back and forth withintheir pumping chambers 2705 create a pulsatile vacuum or full vacuumdelivered to a distal portion of the lumen of the elongate member inpulses of negative pressure. The pulsatile vacuum allows for applicationof full vacuum through the distal shaft 2761 without risk for collapseof the anterior chamber.

In some implementations, the cycles of negative pressure include shortperiods of vacuum interspersed by short periods of decreasing vacuum orno vacuum. In some implementations, the cycles of negative pressureinclude short periods of vacuum interspersed by short periods ofpositive pressure thereby resulting in a short regurgitation of fluidthrough the distal shaft 2761 during each cycle of piston movement.Whether or not positive pressure is applied between the pulses ofvacuum, the pulsatile vacuum creates pulses of discontinuous negativepressure through the elongate shaft that can be between about 10 inHg upto about 30 inHg, preferably as close to full vacuum as possible. Insome implementations, the device can create pulses of discontinuousnegative pressure through the internal lumen of the elongate member at acycling frequency. The device can also create pulses of discontinuouspositive pressure having the same cycling frequency. Thus, the pulses ofdiscontinuous negative pressure are interspersed by the pulses ofdiscontinuous positive pressure. The cycling frequency of the pulses canbe a relatively fast frequency, for example, at least about 0.5 Hz up toabout 5000 Hz, or between 1 Hz and 4000 Hz, or between about 10 Hz up toabout 2000 Hz. The pulses of discontinuous negative pressure aspirate afirst amount of material into the internal lumen through the opening atthe cycling frequency. The pulses of discontinuous positive pressureexpel a second amount of material at the cycling frequency from theinternal lumen through the opening. The volume of material being movedper cycle can vary, but is generally relatively small, for example,between about 0.1 mL up to about 1.0 mL, or approximately 0.5 mL. Insome implementations, the nominal amount of fluid removed per pulse isabout 100 microliters, or between 10 microliters up to about 1000microliters. The second amount of material can be substantially lessthan the first amount of material within this general range of fluidamounts. The pulses of discontinuous negative pressure can beinterspersed by discontinuous periods of lessening vacuum, no vacuum, orpositive pressure at the same frequency.

The vacuum chamber 2703 is configured to be in fluid communication withthe one or more pumping chambers 2705 via a respective opening 2706regulated by a one-way valve 2707. The configuration of the one-wayvalve 2707 can vary including a duckbill valve, ball check valve,lift-check valve, stop-check valve and other types of valves that allowflow of fluid in a single direction and cut-off flow of fluid in theopposite direction. Movement of the pistons 2799 in a first directionwithin the pumping chambers 2705 creates a vacuum such that materialfrom the eye is drawn into the lumen 2763 of the shaft 2761, emptiedinto the vacuum chamber 2703, and pulled through the one-way valve 2707into the pumping chamber 2705. Movement of the pistons 2799 in a second,opposite direction within the pumping chambers 2705 expels material fromthe pumping chamber 2705 and out of the system. The material can beexpelled from the system into a disposal enclosure coupled to an exitport as described elsewhere herein.

The vacuum manifold 2774 can additionally include an evacuation chamber2709. The evacuation chamber 2709 is sealed off from the vacuum chamber2703 such that material drawn into the system can be purged from thesystem without being pushed back out through the shaft 2761. The sealbetween the chambers 2703 and 2709 can be provided by one or moreO-rings 2794. As mentioned, the vacuum chamber 2703 is configured to bein fluid communication with the one or more pumping chambers 2705through respective one-way valves 2707 positioned within openings 2706(see FIG. 28L). The evacuation chamber 2709 is in fluid communicationwith each of the one or more pumping chambers 2705 through otheropenings 2711 regulated by respective valves 2713 (see FIG. 28M). Theconfiguration of the valves 2713 can vary including a ball type checkvalve. As described above, movement of the pistons 2799 in a firstdirection within their respective pumping chambers 2705 (e.g. towards aproximal end of the device 2700) draws material from the vacuum chamber2703 into the pumping chamber 2705 through the valves 2707. Movement ofthe pistons 2799 in a second, opposite direction within their respectivepumping chambers 2705 (e.g. towards the distal end of the device 2700)forces the material into the evacuation chamber 2709 through the valveopenings 2711. During this purge of material, the one-way valves 2707between the one or more pumping chambers 2705 and the vacuum chamber2703 prevents the backflow of material into the vacuum chamber 2703, thelumen 2763, and out the cutting tip. However, the openings 2711 betweenthe one or more pumping chambers 2705 and the evacuation chamber 2709allows for the material to freely enter the evacuation chamber 2709 andultimately out an exit port 2715 of the evacuation chamber 2709 at leastuntil flow is cut off by the valves 2713. As described above, movementof the pistons 2799 in a proximal direction creates a vacuum within thepumping chamber 2705. The ball 2717 of the valve 2713 is pushedproximally by the spring 2719 away from opening 2711 between the pumpingchamber 2705 and the evacuation chamber 2709 thereby opening the valve2713. Upon movement of the pistons 2799 in a distal direction, fluidpressure builds within the pumping chamber 2705 increasing fluidpressure within the chamber and urging the material towards the opening2711 of the valve 2713. The ball 2717 of the valve 2713 is pusheddistally against the spring 2719 such that the spring 2719 compressesand the ball 2717 is urged against the valve opening 2711 therebyclosing the valve (see FIG. 28M). The pumping chambers 2705 aresubstantially devoid of material upon closure of the valve 2713. In someimplementations, one or more of the valves may be slightly compliantsuch as a silicone valve like a duckbill valve. Compliant valves maydeform as a reverse positive pressure is imparted on them. If the valvebetween the vacuum chamber 2703 and the pumping chamber 2705 is acompliant valve, then as the piston is travelling distally andgenerating positive pressure to evacuate the material from the pumpingchamber 2705, the positive pressure may cause a deformation of thecompliant valve. The deformation may cause a small purge orregurgitation of an amount of fluid out the shaft 2761. Thisregurgitation may occur on every back and forth cycle of the piston2799. In some embodiments, the regurgitation may be optimized further bythe design of the pumping chamber 2705. In the pumping chamber 2705, theoutlet opening connecting the pumping chamber 2705 to the evacuationchamber 2709 may be located, for example, on the side of the chamber andconfigured such that the piston 2799 may travel beyond the outletopening. In this embodiment, after the piston 2799 has moved distallybeyond the outlet opening there is no other route for fluid evacuation.Therefore, as the pistons 2799 continue to travel distally creating amoment of positive pressure within the pumping chamber 2705 afterclosure of the valves 2713 that causes a short regurgitation of materialat the distal end of the shaft 2761.

As best shown in FIG. 28J and also FIG. 28N, each of the pistons 2799can include an elongate central piston rod 2721 surrounded by a spring2701 extending between piston heads 2723 a, 2723 b. A distal piston head2723 a and sliding O-ring seal 2794 are positioned within the pumpingchamber 2705. The piston rod 2721, spring 2701, and proximal piston head2723 b are positioned within a piston chamber 2704 within the pistonmanifold 2798 located proximal to the pumping chamber 2705. The distalpiston head 2723 a, sliding seal 2794, and piston rod 2721 are capableof sliding within the pumping chamber 2705 from a proximal end region toa distal end region to create the vacuum pressure. The pumping chamber2705 has an inner dimension that is smaller than the piston chamber 2704and the outer dimension of the spring 2701. Thus, as the piston 2799move towards the distal end region of the pumping chamber 2705, thespring 2701 gets compressed within the piston chamber 2704 between theproximal piston head 2723 b and the lower end of the pumping chamber2705.

The spring 2701 is biased to urge the piston 2799 proximally towards aproximal end of the pumping chamber 2705. A rotating cam 2769 positionedproximal to the pistons 2799 is configured to urge the pistons 2799distally towards the distal end of their respective pumping chambers2705. As the cam 2769 rotates, it applies a distally-directed forcesequentially against the proximal piston heads 2723 b of the pistons2799. The springs 2701 of the pistons 2799 are, in turn, sequentiallycompressed. Upon further rotation of the cam 2769, the distally-directedforce against the proximal piston heads 2723 is sequentially removed andthe springs 2701 sequentially urge the pistons 2799 backwards creating avacuum within the respective pumping chambers 2705 through the one-wayvalves 2707.

As best shown in FIGS. 28J-28K and also FIGS. 28E-28G, a gear head 2752of the motor 2756 can be coupled to the rotating cam 2769 via a motorcoupler 2795. The motor coupler 2795 can have a bore 2789 in a proximalend configured to receive the gear head 2752 and one or more projections2796 on a distal end. The projections 2796 are configured to abut andengage with corresponding wedged-shaped projections 2797 on the proximalend of the cam 2769. The cam 2769 rotates as the gear head 2752 rotates.A distal end of cam 2769 has a cam surface 2725 configured to providereciprocal linear motion of the pistons 2799. The cam surface 2725 canbe elliptical, eccentric, egg, or snail-shaped. During a first fractionof rotation of the cam 2769, the proximal piston heads 2723 b slidealong the ramped portion of the cam surface 2725 and the piston 2799 ismoved distally along the longitudinal axis of the device. During asecond fraction of rotation of the cam 2769, the proximal piston heads2723 b slide past the cam surface 2725 such that the distally-directedforce against the pistons 2799 by the cam 2769 is released. The spring2701 surrounding the piston rod 2721 urges the proximal piston head 2723b in a proximal direction towards the proximal end region of the pistonchamber 2704. A complete revolution of the cam 2769 therefore allows foraxial movement of each piston 2799 in succession. Movement of theelongate member 2755 can occur using a similar rotating cam mechanism,as will be described in more detail below.

As best shown in FIG. 28N, a piston stop 2727 can be coupled to aproximal end region of the piston manifold 2798. The piston stop 2727can be a generally cylindrical element surrounding the rotating cam2769. A distal end region of the piston stop 2727 can define one or moreprojections 2729 configured to project into a proximal end region ofeach of the piston chambers 2704 in the piston manifold 2798. Theprojections 2729 abut against the proximal piston heads 2723 b ofrespective pistons 2799 when positioned at a proximal-most end region oftheir respective piston chambers 2704. For example, if the device 2700includes three pistons 2799 positioned in three piston chambers 2704,the piston stop 2727 includes three projections 2729 configured to abutagainst the proximal piston head 2723 b of each of the three pistons2799. The piston stop 2727 provides a hard stop to the linear travel ofthe pistons 2799 in a proximal direction upon expansion of the springs2701 and thus, the overall volume of the pumping chamber 2705 that canbe achieved. The relative position of the projections 2729 within thepiston chambers 2704 can be adjustable. In some implementations, anadjustment ring 2730 can be positioned around an outer surface of thepiston stop 2727 and available to a user through one or more windows2731 in the housing of the hand-held portion 2760 (see FIGS. 28A-28B).The adjustment ring 2730 can have a threaded inner surface configured toengage with a corresponding pin 2732 on an outer surface of the pistonstop 2727. The pin 2732 is configured to slide within the threads of theadjustment ring 2730 such that the piston stop 2727 travels axiallyalong the longitudinal axis of the device. As the piston stop 2727 isadjusted to be positioned further distal relative to the piston manifold2798, the projections 2729 extend further into the piston chambers 2704and limit the linear travel of the pistons 2799 in the proximaldirection upon expansion of the springs 2701. This, in turn, limits thesize of the pumping chamber 2705. As the piston stop 2727 is adjusted tobe positioned more proximally relative to the piston manifold 2798, theprojections 2729 are withdrawn from the piston chambers 2704 and do notlimit (or limit to a lesser degree) the linear travel of the pistons2799 in a proximal direction upon expansion of the springs 2701. This,in turn, maximizes the size of the pumping chamber 2705.

The hand-held portion 2760 of the device 2700 can be formed of arelatively rigid, lightweight material(s). At least a portion of thehand-held portion 2760 can be removable such that the device 2700includes a durable portion configured to be reused (e.g. the motor 2756and related components) and a disposable portion (e.g. the componentscoming into contact with human tissue or fluids). In someimplementations, the hand-held portion 2760 includes a disposable fronthousing portion configured to couple with a durable back housingportion. The two housing portions can couple together using a variety ofmechanisms such as threads, snap-lock, and the like. The couplingmechanism can include a release button configured to uncouple the twohousing portions.

As discussed above, the amount of pulsatile vacuum can be adjusted bylimiting the travel of the pistons in a rearward direction such as witha piston hard stop. In some implementations, the relative relationshipof the disposable to reusable portions is adjustable and, in turn, canlimit the distance the pistons can travel backwards. For example, thefurther the reusable portion is positioned onto the disposable portion,the more limited the piston travel is due to the piston hard stop. Theposition of the piston stop can be adjustable to provide a plurality ofselectable vacuum settings. In some procedures or certain steps of aprocedure, higher pressures may be more desirable than in otherprocedures or steps of the procedure. The higher pressure can beselected, for example, by actuating the piston stop to a wider settingsuch that the piston can travel a longer distance per cycle and maximumvacuum achieved. In some implementations, the piston stop position canbe toggled between a “high vacuum” position and a “low vacuum” positionby clicking an adjustor. In other implementations, the piston stoppositioned can be “dialed in” to any of a plurality of vacuum settingsthat are conveniently selected during use.

In some implementations, the vacuum source can create a sudden rise invacuum forming a vacuum profile that causes the cornea and the eye toeffectively “bounce” up and down during application of pulsed vacuum.For example, when the pistons 2799 are sprung backwards they can createthe sudden rise in vacuum forming a vacuum profile that resembles a “sawtooth” (i.e. suction-pause-suction). Limiting the backwards travel ofthe pistons 2799 inside their respective pumping chambers 2705 canreduce the amount of suction impact or shock that is created each timethe pistons are sprung backwards. The piston limit thereby limits themaximum suction created with each piston travel reducing the impact thisabrupt suction can have on the eye. The aspiration forces created witheach backwards travel of the piston 2799 can be greater than 500 mmHg upto about 700 mmHg.

In some implementations, the device is limited from achieving maximumvacuum by incorporating a feature that automatically bypasses the shaft2761 depending on whether a threshold vacuum is reached. For example, ableed valve or other bypass mechanism can be incorporated to prevent athreshold amount of vacuum from being applied at a distal opening of theshaft 2761 and into the eye. A bypass to turn on or off the suction canlimit the maximum amount of vacuum that can be generated within the eyeeven if the opening into the shaft 2761 is clogged. This bypass canprevent the vacuum from building in the event of a blockage to createless surge upon removal of that blockage. The bypass mechanism can beadjustable or selective such that a user can choose whether or not theywant the potential for maximum vacuum or something less than maximumvacuum applied.

As mentioned above, the shaft 2761 can include an irrigation sleeveconfigured to deliver irrigation to the work site. FIGS. 32A-32Billustrates an implementation of the device having an irrigation sleeve3127 near a distal end region of the shaft 2761. The irrigation sleeve3127 can include one or more irrigation openings 3125 configured todeliver fluid from the irrigation lumen 3123 to the eye during use. Insome implementations, the device can incorporate a compliant element incommunication with the irrigation flow path. The compliant element canbe a balloon or other fillable element or reservoir configured to storean amount of fluid from the irrigation lumen 3123. The compliant elementcan fill with irrigation fluid such that in the event of a blockage anda sudden rush of vacuum through the distal opening of the shaft 2761,the irrigation fluid stored up in the compliant element can be availableto fill in the volume removed by the increased vacuum. The fluid fromthe compliant element can be pulled into the eye upon the increase innegative pressure to maintain a balance in pressure within the eye toavoid damage or collapse of the anterior chamber.

As described elsewhere herein, the elongate member or shaft of thedevices described herein can be oscillated relative to the hand-heldportion of the device by a drive mechanism operatively coupled to theelongate member. The drive mechanism can be powered via a cableextending through the housing or by one or more batteries. Power can beapplied to the device 2700 via one or more actuators or inputs such as atrigger, button, slider, dial, keypad, touchscreen, footswitch, or otherinput device as described elsewhere herein. The input and power can bepositioned on the device itself or remote from the device. The devicecan further include a control processor responsive to the user input andpower. The control processor can control one or more aspects of thedrive mechanism. The control processor can be programmable and acceptuser input to adjust various adjustable functions of the device (i.e.travel distance of the elongate member, oscillation frequency of theelongate member, extension speed profile, retraction speed profile,maximum extension speed, maximum retraction speed of the elongatemember, vacuum level, etc.). The control processor can be programmed byan input on the device itself or programmed remotely such as by anexternal computing device having an input. The control processor canoperate according to program instructions stored in a memory.

Control of the drive mechanism can be completed through the use of amotion controller, electronic speed controller, or the like. Theactuator or input for the motion controller of the can be an on/off sortof input to initiate cutting and/or vacuum. Alternatively, the input forthe motion controller can be a multi-way input that causes, for example,the motor 2756 to spin faster depending on degree of actuation of theinput (e.g. pressing further down on a button, dialing up a dial,tapping a displayed key on a touchpad, or sliding a further distance ina direction relative to the housing). The controller can be programmed(e.g. remotely or on the device itself) to have a minimum and/or maximumspeed upon actuation of the input, as will be described in more detailbelow.

FIGS. 33A-33C illustrate different configurations of an implementationof a multi-way input 3125, such as a trigger, on the device configuredto control various functions of the device. The input 3125 can have aplurality of positions configured to turn on or off (or increase ordecrease) one or more functions of the device. For example, the input3125 can have a resting position as shown in FIG. 33A. The user canactuate the input 3125 to move into a first actuated position (e.g. apartially depressed position) configured to start or increase at leastone or more functions of the device (see FIG. 33B). The first actuatedposition can turn on both vacuum and oscillation of the distal shaft2761 thereby providing vacuum-plus-cutting function. The input 3125 canhave a second actuated position (e.g. fully depressed position)configured to pause or decrease one or more functions of the device (seeFIG. 33C). For example, the input 3125 in the second actuated positioncan suspend oscillation of the shaft 2761 while the vacuum through theshaft 2761 continues thereby providing a vacuum-only function.

Various configurations of the input are considered herein. As an exampleconfiguration, the input 3125 can be mechanical such that it couple to arod 3127 that is movable along a longitudinal axis of the device as theinput 3125 is actuated into one of a plurality of positions (shown inFIGS. 33B-33C). For example, when the input 3125 is moved from theresting position into the first actuated position, the input 3125 canmove the rod 3127 such that a proximal end of the rod 3127 extends afirst distance into a proximal portion of the hand-held portion of thedevice (FIG. 33B). When the input 3125 is moved from the first actuatedposition into the second actuated position, the input 3125 can move therod 3127 such that the proximal end of the rod 3127 extends a seconddistance into the proximal portion of the handheld portion of the device(FIG. 33C). The proximal end of the rod 3127 can interact with anelement within the handheld portion of the device configured to changethe speed of the motor configured to oscillate the elongate shaft 2761,for example, by a potentiometer.

The rod 3127 in addition to changing the speed of oscillation canprevent movement of the shaft 2761 altogether. As described above,movement of the rod 3127 can cause it to change the speed of the motorby interacting with a potentiometer or other feature. Movement of therod 3127 in a proximal direction P can also move the shaft 2761 in aproximal direction thereby preventing the proximal end of the shaft 2761from interacting with the drive mechanism configured to cause the shaft2761 to oscillate (e.g. camming teeth). FIGS. 34A-34C correspond toFIGS. 33A-33C and FIGS. 35A-35C. Each of the figures illustrate howmovement of the actuator 3125 and the rod 3127 affect movement of theshaft 2761 relative to a camming mechanism. In the resting state of theactuator 3125 shown in FIG. 34A, the rod 3127 is in a distal-mostposition and moved away from a proximal spline 3162 of the shaft 2761.Under normal operation and as described elsewhere herein, the rotatingcam 3169 can continuously spin. As it spins, the rotating cam 3169causes the teeth 3132 of the cam follower 3190 to engage and effectivelypull the cutter spline 3162 backward until it reaches the step 3933 (seeFIGS. 35A-35C) at which point the force of the spring 3135 urges theshaft 2761 forward or in a distal direction D. The shaft 2761 oscillatesback and forth as the cam 3169 spins. Upon full actuation of theactuator 3125, the rod 3127 is moved further in a proximal direction Puntil a feature 3163 of the rod 3127 engages with the spline 3162 of theshaft 2761 (see FIGS. 34C and 35C). The rod 3127 pulls the splineproximally. The movement disengages the cam 3169 from the cam follower3190 preventing the teeth 3132 from engaging such that no motion of theshaft 2761 occurs.

In some implementations, the device 2700 is an all-in-one device inwhich the only linkage to the instrument may be for power. Thus, theall-in-one device may not have any foot pedal or other linkage forcontrol.

The device 2700 may also battery-powered. The battery can beincorporated within a region of the housing, either internally orcoupled to a region of the housing such as within a modular, removablebattery pack. The battery can have different chemical compositions orcharacteristics. For instance, batteries can include lead-acid, nickelcadmium, nickel metal hydride, silver-oxide, mercury oxide, lithium ion,lithium ion polymer, or other lithium chemistries. The device can alsoinclude rechargeable batteries using either a DC power-port, induction,solar cells, or the like for recharging. Power systems known in the artfor powering medical devices for use in the operating room are also tobe considered herein. In some implementations, rather than the batteryback mounted on or in the handle, which can increase the size of thehandle, the battery pack can be mounted elsewhere such as on a user'sarm or wrist of the arm holding the instrument during a procedure. Ashort cable connector can connect the mounted battery back to the devicesuch that only this linkage extends from the handle of the device 2700during use. Thus, no foot pedal or other tethering connection need belinked to the device 2700. This can provide the user with moreportability, flexibility, and freedom of movement and without worryingabout catching cables or other tethers during use.

As mentioned above, the devices described herein can include a shaftconfigured to be inserted into the eye in a minimally-invasive manner tocut, aspirate, and/or inject material in the eye. The shaft can be avitrectomy-style cutting element having a hollow, elongate memberextending through an outer member with a side opening configured tocapture and cut pieces of tissue. The shaft can also include aphacoemulsification (“phaco”) style tip, which also includes a movableelongate member with or without an outer member. Oscillating movementsof the elongate member can occur using any of a variety of mechanisms,such as a rotating cam element as described elsewhere herein. Theoscillating movements can be created in a manner that avoids thedeleterious effects typical of phacoemulsification on the delicate eyetissues such as corneal endothelial cells.

Phacoemulsification can incorporate two main methods of action: 1)mechanical jack hammering, and 2) cavitation. In the case ofjackhammering, the oscillating movements of the tip mechanically knocksinto the lens tissue at a high speed to break up the tissue into eversmaller fragments. Cavitation involves the creation of a vacuum andfluid bubbles during oscillating movements of the tip. As the phaco tipretracts in the fluid, the speed of its movement is so fast that itcavitates, or creates a vacuum created by the retracting tip causing theformation of bubbles as gas is drawn out of the fluid. These bubblesimplode under very high temperature (e.g. 3000° C.) and very highpressure (e.g. 10,000 atm). It is generally thought that the combinationof high temperatures and high pressure helps to break down the lenstissue fragments. While the role cavitation plays in breaking up thelens material is debatable, the role cavitation plays as the primarydriver behind the deleterious effects of phacoemulsification on thesurrounding lens tissue during cataract surgery is not. Hightemperatures, shock waves, and the creation of free-radicals in the eyeare of concern to the health of the corneal endothelial cells.

In an implementation, one or more of the devices described herein caninclude an oscillating tip configured to move in a manner that reduces,attenuates, or prevents problems of cavitation duringphacoemulsification. The oscillating tip can be incorporated in an“all-in-one” sort of device having a vacuum source within the handle toapply pulsatile vacuum. Alternatively, the oscillating tip can beincorporated in a device used in connection with another deviceconfigured to apply pulsatile vacuum remotely. As described above, thevarious features and functions of the devices described herein can beapplied to conventional devices and systems known in the art to beuseful for cutting, fragmenting, emulsifying, or otherwise impactingtissues at or near a surgical site. For example, the pulsatile vacuumand/or asymmetric motion profiles described herein can be incorporatedinto phacoemulsification systems and vitrectomy systems known in theart. For example, the features described herein can be incorporated asan additional hardware or software feature of the phacoemulsificationsystems that are conventionally used to cause oscillation of an elongateshaft in the ultrasonic range of frequencies (e.g. above 20,000 Hz).

FIGS. 29A-29C illustrate an implementation of a device 2900 having ahand-held portion 2960 coupled to a distal shaft 2961. The distal shaft2961 can include an elongate member 2955 configured to oscillaterelative to the hand-held portion 2960. The elongate member 2955 can,but need not, extend through a tubular outer member 2959 (see FIGS.29G-29H). The elongate member 2955 can include a distal tip 2965. Thedevice 2900 can include a drive mechanism operatively coupled to thedistal shaft 2961 and configured to drive movement of the tip 2965. Aswill be described in more detail below, the drive mechanism can beoperatively coupled to the elongate member and configured to oscillatethe elongate member. When in use, the drive mechanism is capable ofretracting the elongate member in a proximal direction with a retractionspeed profile and advancing the elongate member in a distal directionwith an extension speed profile. The retraction speed profile can bedifferent from the extension speed profile.

In some implementations, the elongate member 2955 can be connected to ahub 2987. The hub 2987 can have camming surfaces 2992 on its distalsurface that engages with a rotating cam 2969. The proximal surface ofthe hub 2987 can be connected to a spring 2935 that pushes the hub 2987distally. The distal shaft 2961 can include an elongate member 2955extending through an outer member 2959, although it should beappreciated that no outer member 2959 is necessary. The elongate member2955 is also connected to an orientation locking feature 2928 such as arectangular block that prevents the elongate member 2955 and the hub2987 from rotating. As the rotating cam 2969 rotates, the cammingsurfaces 2992 cause the hub 2987 to move proximally, compressing thespring 2935 further. The camming surfaces 2992 have a step 2933 thatallows the hub 2987 to drop forward (i.e. distally) again at a certainpoint in the rotation. At this point, the spring 2935 pushes the hub2987 quickly forward until the camming surfaces 2992 engage again.Through such a mechanism, the tip 2965 of the elongate member canretract with a retraction speed profile that is at least in part afunction of the rotational speed of the rotating cam 2969. Therotational speed of the rotating cam 2969 can be controlled so that themaximum tip retraction speed remains below a ‘cavitation thresholdspeed’ for generating cavitation bubbles in the eye. The tip 2965 of theelongate member can then extend with an extension speed profile that isat least in part a function of the force of the spring 2935 and mass ofthe tip assembly. In this way, the average retraction speed can be slow,i.e. below the cavitation threshold, but the average extension speed canbe fast, i.e. close to or higher than the average retraction speed of atypical phacoemulsification tip. Thus, the benefits of mechanicaljackhammering can be achieved while the deleterious effects ofcavitation are substantially avoided.

FIGS. 30A and 30C illustrate typical motion profiles of conventionalphacoemulsification tips. Conventional phacoemulsification tips have asubstantially sinusoidal motion profile in which the average speed ofthe tip is substantially the same during proximal retraction as duringdistal extension (see FIG. 30A). In contrast, the oscillating elongatemember of the devices described herein have a generally non-sinusoidalmotion profile in which the average tip speed of the retraction speedprofile and the average tip speed of the extension speed profile can besubstantially different providing an overall asymmetric movement profilefor the oscillating elongate member (see FIG. 30B). Additionally,conventional phacoemulsification tips have maximum tip speed (V_(maxR))of the retraction speed profile R that is substantially the same as themaximum tip speed (V_(maxE)) of the extension speed profile E and thus,their motion profiles substantially overlap (see FIG. 30C). Theoscillating elongate member of the devices described herein have maximumtip speed (V_(maxR)) of the retraction speed profile R that issubstantially the lower than the maximum tip speed (V_(maxE)) of theextension speed profile E and thus, their motion profiles do notsubstantially overlap (see FIG. 30D).

FIG. 30C illustrates a motion profile provided by a conventionalphacoemulsification machine in which the extension and retraction speedprofiles are substantially the same. For example, a 40,000 Hz phacomachine having a 0.1 mm amplitude speed may have a V_(max) ofapproximately 12.6 meters/second where the time T₁ is approximately0.0125 ms. FIG. 30D illustrates a motion profile provided by the devicesdescribed herein. The V_(maxE) may be substantially the same as V_(maxE)of a conventional phacoemulsification machine, but the V_(maxR) may besubstantially lower such that full retraction is complete at time T₂.Thus, the device may have a lower V_(avg).

FIGS. 30E-30F illustrate additional asymmetric motion profilesconsidered herein. The extension speed E can increase linearly toV_(maxE) as the spring force compels the elongate member forward untilit reaches its stroke limit and drops back off to zero before beingretracted. As the elongate member is retracted (e.g. as the cam rotatesit pulling the elongate member back at a roughly constant speed), theretraction speed R increases to V_(maxR) before slowing back down to astop. The retraction speed profile R can form a plateau during whichtime the retraction speed is roughly constant. Retraction phase iscomplete at time T₂, which is longer than the time T₁ it took tocomplete the extension phase. There can include period of dwell or apause between extension and retraction phases. The V_(maxE) can beroughly the same as conventional phaco machines (e.g. between about 8 to12 meters/second). The V_(maxR) can be much lower than conventionalphaco machines (e.g. less than about 0.02 meters/second). It should beappreciated that speeds of extension and retraction can vary and thatany of a number of non-sinusoidal tip motion profiles are consideredherein. In some implementations the V_(maxE) can be between about 2meters/second and 50 meters/second and the V_(maxR) can be between about0.001 meters/second and 2 meters/second.

In conventional phacoemulsification, the speed profile and movementprofile of the movable elongate member are generally sinusoidal.Meaning, the movement of the distal tip of the elongate memberoscillates in a sine wave pattern, for example, corresponding to asupplied voltage to the piezoelectric crystal. The speed of the distaltip therefore also oscillates in a sinusoidal manner as the derivativeof the movement profile. FIG. 30G shows an implementation ofnon-sinusoidal movement of the distal tip of an elongate member (bottompanel) relative to its extension and retraction speed profiles (toppanel). Both the speed profiles and the corresponding movement profilesare shown as being non-sinusoidal. The distal tip can have a dwell timebetween the extension and retraction cycles. Between t₀ and t₁, thedistal tip can extend forward with a speed profile that may be a sinewave or any other profile. At t₁, the distal tip can pause for a dwellperiod between t₁ and t₂. The dwell period can be about 0.050milliseconds, or between about 0.001 and 0.025 milliseconds. At t₂, thedistal tip can retract with a speed profile that may also follow a sinecurve. The movement of the distal tip resembles a sine wave having adwell at its most extended position.

The non-sinusoidal patterns, for example as shown in FIG. 30G, canreduce the likelihood of cavitation because the dwell time allows forthe fluid in the eye that is displaced by movement of the elongatemember during extension to return to a zero momentum state beforeretraction of the elongate member begins. During conventional sinusoidalpatterns, the elongate member pushes the fluid away from the distal tipand then retracts immediately while the fluid may still be travelingaway from the distal tip thereby increasing the likelihood of cavitationdue to the relative velocity of the fluid to the distal tip. Therelative velocity of the fluid to the distal tip is higher if the fluidof the eye is being carried away from the tip by momentum while thedistal tip itself begins retracting. The dwell period can allow thefluid being displaced to return towards a zero momentum or zero velocitystate before the distal tip begins to retract. In this implementation,the extension speed profile and the retraction speed profile may besimilar or identical, but the overall speed profile and movement of thedistal tip is non-sinusoidal. Other implementations are contemplatedherein. For example, the elongate member can slow down more gradually asit approaches its fully extended position than a typically sine wavepattern would. As the elongate member retracts, the profile would followa more symmetric path. Any number of other non-sinusoidal patterns areconsidered.

It should be appreciated that the term “non-sinusoidal” as used hereincan be defined as a movement or speed profile that does not follow asimple sine wave pattern of oscillating movement. A simple sine wave maybe defined by a single frequency, a single phase shift, and a singleamplitude. Certain complex profiles may be generated by adding orsubtracting sine waves. However, these complex profiles may also beconsidered non-sinusoidal because their addition or subtraction does notfollow a simple sine wave pattern.

The drive mechanism is capable of retracting the elongate member in aproximal direction with a retraction speed profile and advancing theelongate member in a distal direction with an extension speed profilesuch that the retraction speed profile is different from the extensionspeed profile. The average retraction speed of the elongate member fromthe retraction speed profile can be lower than the average extensionspeed of the elongate member from the extension speed profile. Thus, thedrive mechanism operatively coupled to the elongate member is configuredto asymmetrically oscillate the elongate member. The extension speedprofile E can include a V_(maxE) and the retraction speed profile R caninclude a V_(maxR) where the V_(maxR) is less than the V_(maxE). TheV_(maxR) of the elongate member is generally kept below a thresholdspeed at which cavitation bubbles would be generated in the eye. Withoutlimiting this disclosure to any particular threshold speed, one of skillin the art would understand the theoretical speed of retraction at whichcavitation bubbles may be generated is generally about 5 meters/second.As such, the V_(maxR) of the elongate member may be maintained belowabout 5 meters/second.

The oscillating movements of elongate members driven by conventionalphacoemulsification systems may have a degree of variability due tonormal losses during movement (e.g. due to friction or otherenvironmental factors). This variability may impact the average speedsachieved during retraction and extension such that the retraction speedprofile and extension speed profile are not identical or perfectlysinusoidal. However, this normal variability during movements ofcomponent parts is not intentionally engineered or designed to occur(i.e. a control processor operating according to program instructionsstored in a memory; or hardware in operable communication with thecontrol processor designed to achieve different speeds depending onphase of cycling). Thus, normal variability in speed during movement isnot considered to be contributing to or resulting in an asymmetricmotion profile. The asymmetric motion profiles described herein areconsciously engineered or designed motion profiles intended to besubstantially reproducible during each cycling and not merely due tochance variability.

As described elsewhere herein, the vacuum source of the device can beconfigured to provide pulses of discontinuous negative pressure. A pulseof aspiration can be drawn through the lumen of the elongate memberduring at least a portion of the extension as the elongate member movesin a distal direction and/or during at least a portion of the retractionas the elongate member moves in a proximal direction. FIG. 31Aillustrates an implementation of a vacuum profile over time for thepulsatile vacuum applied through the distal end region of the lumen ofthe elongate member. As described elsewhere herein, the vacuum sourcecan include a pump having a plurality of pistons configured to movesequentially within their respective pumping chambers creating periodsof increasing vacuum interspersed by periods of decreasing vacuum. Insome implementations, the increase in vacuum can occur faster than thedecrease in the vacuum providing a vacuum profile. The pulsatile vacuumprofile applied through the lumen of the distal shaft can besynchronized with the motion profile of the elongate member performingthe cutting such that at least a part of the period of negative pressureis applied during a certain phase of movement. FIGS. 31B-31C show themovement of the elongate member (solid lines) relative to the periods ofnegative pressure (hatched lines) applied through the elongate member.The period of negative pressure (i.e. vacuum pulse) can occur during atleast part of the forward stroke or distal extension E of the elongatemember, dwell time after distal extension E and before proximalretraction R, and/or during at least part of the proximal retraction Rof the elongate member. For example, FIG. 31B shows a first pulse ofvacuum pressure occurs during the extension E of the elongate member aswell as the dwell time after extension E and before retraction R. Thefirst pulse of vacuum pressure ends during the retraction R phase and asecond pulse of vacuum begins and ends before the same retraction phaseends. FIG. 31C shows another implementation where a first pulse ofvacuum pressure begins during extension E of the elongate member and ismaintained during retraction R phase of the elongate member as well asduring a second extension E of the elongate member. FIG. 31B shows thevacuum pulse having about 2× the frequency of tip movement and FIG. 31Cshows the tip movement having about 2× the frequency of the vacuumpulse. Both FIG. 31B and FIG. 31C show vacuum pulse occurring during aportion of the extension E and retraction R. It should be appreciatedthat any number of various relative frequencies are considered hereinand that these are illustrations of some examples of the relative speedprofiles and vacuum profiles.

The displacement or travel distance of the tip 2965 can vary, but isgenerally greater than phacoemulsification tips known in the art.Typical phacoemulsification tips have a tip displacement of on the orderof about 0.1 mm and move at a frequency of between about 20-40 kHz. Thetips 2965 described herein can have a greater displacement distance anda lower frequency. For example, the displacement achieved by the tip2965 can be between about 0.05 mm-1.0 mm at a frequency of about10-2,000 Hz. In this way, the devices described herein may not beultrasonic and may not generate the heat associated with harmful effectsin the eye during cataract surgery. In some implementations, the tip2965 is pushed forward by a spring 2935. A longer stroke distance canallow for the tip to achieve a higher final speed V_(maxE) at the timeof impact with eye tissue.

In some implementations, the device 2900 can have an outer tube 2959that extends over an elongate member 2955 (see FIGS. 29G-29H). Relativelengths of the inner and outer members 2955, 2959 can be such that adistal tip 2965 of the elongate member 2955 extends beyond a distal endof the outer member 2959 when it is fully extended in a distal directionforming a fully extended configuration. The distal tip of the elongatemember 2955 in the fully extended configuration is positioned distal ofa distal opening of the outer member 2959. A distance between the distalopening of the outer member 2959 and the distal tip of the elongatemember 2955 in the fully extended configuration defines an extensiondistance D. The elongate member 2955 fully retracts into the outermember 2959 when it is in a fully retracted position. The distance thedistal tip of the elongate member 2955 moves relative to the outermember 2959 from the fully retracted configuration to the fully extendedconfiguration defines a travel distance. The extension distance can beless than the travel distance, for example, half the travel distance. Insome configurations the travel distance is between about 0.05 mm toabout 1.0 mm and the extension distance is between about 0.1 mm to about0.5 mm. Therefore, the distal tip 2965 of the elongate member 2955 canbe only exposed to the lens material for a portion of its motionprofile. For example, the elongate member 2955 may extend forward about0.5 mm from its fully retracted position and approximately half of thisstroke may be within the outer member 2959 such that only the last 0.25mm of the stroke the elongate member 2955 extends beyond the outermember 2959. In this way, the elongate member 2955 can accelerate to ahigh speed before it impacts the lens material. Retraction of theelongate member 2955 fully into the outer member 2959 provides a furtherbenefit in that it may help separate lens material from the distal tip2965 of the elongate member 2955 as it retracts into the outer member2959 preventing the lens material from ‘lollipopping’ onto the distaltip 2965 of the elongate member 2955.

The drive mechanism operatively coupled to the elongate member 2955configured to cause oscillating movements of the elongate member 2955can vary as described elsewhere herein. In some implementations, theelongate member 2955 can be driven by a drive mechanism incorporating aspring element 2935. However, other energy modalities are consideredherein for driving the elongate member 2955 in the asymmetric ornon-sinusoidal manner discussed herein. For example, the elongate member2955 can be driven mechanically, hydraulically, pneumatically,electromagnetically, or via a piezoelectric drive system as describedbelow. One of skill in the art would understand the structures necessaryto implement various drive mechanisms so as to move the elongate memberas described herein.

In some implementations, the drive mechanism of the device canincorporate a piezoelectric element configured to drive the elongatemember, such as by driving the hub 2987 forward and backward. Thepiezoelectric element can respond to changes in voltage by decreasing orincreasing in size. A high frequency voltage connected to thepiezoelectric element can generate a motion profile of the tip 2965 thatmatches the frequency of the supplied voltage. The voltage signals sentto the piezoelectric element can be generally non-sinusoidal in shapeand therefore the tip 2965 moves in a generally non-sinusoidal patternas described elsewhere herein. The voltage may have a waveform thatcontracts the piezoelectric elements slower than it allows them toexpand. This moves the tip 2965 slower on the retraction stroke than onthe extension stroke. Any number of motion profiles may be commandedbased on the voltage waveform supplied to the piezoelectric element. Forexample, two or more overlapping voltage sinusoidal waveforms can besupplied to the piezoelectric element that creates an interferenceeffect such that a non-sinusoidal wave form is created.

In still further implementations, a combination of mechanisms andmodalities are incorporated in the device to drive the elongate memberwith a non-sinusoidal motion profile. For example, an electromagneticcoil can be configured to move a ferritic core forward with theapplication of a current through the coil. The core can be configured tobe driven forward by the electromagnetic coil, but then retractbackwards (i.e. proximally) through the force of a compressed spring.Therefore, with an increase in current through the coil, the core isdriven forward. With the current is reduced, the core retracts backward.In this manner, the core may be connected to a cutter member so that theextension forward can be executed quickly by the sudden increase incurrent in the coil, but the retraction may be slower by the force ofthe compressed spring.

The devices described herein can be actuated using one or more inputsincluding a trigger, button, slider, dial, keypad, switch, touchscreen,foot pedal, or other input that can be retracted, pressed, squeezed,slid, tapped, or otherwise actuated to activate, modify, or otherwisecause the oscillation, aspiration, and/or infusion of fluid through theelongate member. The actuators can be incorporated into the deviceitself or can be remote from the device, but in wired or wirelesscommunication with the device such as on an external computing devicehaving its own inputs. As described elsewhere herein, the device the oneor more inputs can be urged by a user into a position that causes thedrive mechanism to increase the frequency of oscillation of the elongatemember the more the trigger is actuated (e.g. by increasing the spinningof a motor).

The devices described herein can also be programmed to provide limits ona particular action upon actuation of the input. For example, the drivemechanism can be programmed to have a minimum and/or maximum speed uponactuation of the input or, in the case of fluid infusion and aspiration,the device can be programmed to have a minimum and/or maximum fluidpressure upon actuation of an input. Thus, the devices described hereincan be programmed using inputs adjustable by a user as well as bypre-programmed instructions that impact the one or more aspects of thedevice upon actuation of the inputs.

The devices described herein can include a controller in operativecommunication with one or more components of the drive mechanism, thevacuum source, or other components of the device including an externalcomputing device. The controller can include at least one processor anda memory device. The memory can be configured for receiving and storinguser input data. The memory can be any type of memory capable of storingdata and communication that data to one or more other components of thedevice, such as the processor. The memory may be one or more of a Flashmemory, SRAM, ROM, DRAM, RAM, EPROM, dynamic storage, and the like. Thememory can be configured to store one or more user-defined profilesrelating to the intended use of the device. The memory can be configuredto store user information, history of use, measurements made, and thelike.

The devices described herein can include a communication module inoperative communication with one or more components of the device, suchas the controller. The communication module can communicate with anexternal computing device having a communication module. The connectionbetween the communication module of the device and the externalcomputing device can include a wired communication port such as a RS22connection, USB, Firewire connections, proprietary connections, or anyother suitable type of hard-wired connection configured to receiveand/or send information to the external computing device. Thecommunication module can also include a wireless communication port suchthat information can be fed between the device and the externalcomputing device via a wireless link, for example, to displayinformation in real-time on the external computing device aboutoperation of the device, and/or control programming of the device. Forexample, a user can program the speed profile of the motor 2756 of thedevice on the external computing device. Any of a variety of adjustmentsto and programming of the device can be performed using the externalcomputing device. The wireless connection can use any suitable wirelesssystem, such as Bluetooth, Wi-Fi, radio frequency, ZigBee communicationprotocols, infrared, or cellular phone systems, and can also employcoding or authentication to verify the origin of the informationreceived. The wireless connection can also be any of a variety ofproprietary wireless connection protocols. The external computing devicewith which the device communicates can vary including, but not limitedto, desktop computer, laptop computer, tablet computer, smartphone, orother device capable of communicating and receiving user input.

The processor, memory, storage devices, input/output devices can beinterconnected via a system bus. The processor can be capable ofprocessing instructions for execution within the system. Such executedinstructions can implement one or more of the processes described hereinrelated to the use of the device. The processor of the controller can bea single-threaded processor or a multi-threaded processor. The processorof the controller can be capable of processing instructions stored inthe memory and/or on a storage device to provide an output ofinformation to the user about operation of the device.

One or more aspects of the device can be programmed by a user. Forexample, one or more aspects of the drive mechanism can be programmed bya user to control the motion of the elongate member including, but notlimited to travel distance of the elongate member, frequency ofoscillation of the elongate member, maximum extension speed (V_(maxE)),minimum extension speed (V_(minE)), maximum retraction speed (V_(maxR)),minimum retraction speed (V_(minR)), average extension speed (V_(avgE)),average retraction speed (V_(avgR)), or any other aspect of the motionprofile. In some implementations, the distance the elongate member moveswith each cycle can be adjustably programmed such that the amplitude ofits oscillation is selectable within a range of about 0.5 Hz to about5000 Hz, or in a range of about 10 Hz to about 2000 Hz. The amplitude ofoscillation can be less than ultrasonic, for example, less than about20,000 Hz or within the ultrasonic range (e.g. about 20,000 Hz, to about120,000 Hz, up to the gigahertz range).

One of more aspects of the vacuum source can also be programmed by auser to control the vacuum applied at the distal end region of theelongate member including, but not limited to flow rate of aspiration,minimum vacuum pressure, maximum vacuum pressure, frequency of vacuumpulses, or any other aspect of the vacuum profile. In someimplementations, the flow rate of aspiration can be adjustablyprogrammed within a range of between about 5-100 ml/min.

The devices described herein can be used such that one or more aspectsare manually controlled and/or adjusted according to manual inputs bythe user. The devices described herein can be programmed to control theone or more aspects. The controller can include software capable ofbeing programmed to adjust or provide limits on the one or more aspectsof the device. Thus, the software run by the controller can providecertain aspects of the device without any user input during use. In animplementation, the adjustments or programming can be via a controllerthat is controlled by software, either within the device or on anexternal computer device. A user can program the controller remotely viaan external computing device in communication with the device via awireless connection such as BlueTooth.

It should also be appreciated that the asymmetric motion profile with orwithout the vacuum pulse described herein can be applied to knownphacoemulsification systems typically used for cataract surgery andvitrectomy. Conventional phacoemulsification systems configured to movean elongate member at ultrasonic frequency to remove lens material canimplement the one or more motion profiles and/or vacuum profiles asdescribed herein via software or hardware, for example by circuitsproviding a certain voltage causing the asymmetric movements. Thus, theasymmetric motion profiles and pulsed vacuum profiles described hereincan be applied to a machine configured to oscillate at ultrasonicfrequencies.

Aspects of the subject matter described herein may be realized indigital electronic circuitry, integrated circuitry, specially designedASICs (application specific integrated circuits), computer hardware,firmware, software, and/or combinations thereof. These variousimplementations may include an implementation in one or more computerprograms that are executable and/or interpretable on a programmablesystem including at least one programmable processor, which may bespecial or general purpose, coupled to receive signals, data andinstructions from, and to transmit signals, data, and instructions to, astorage system, at least one input device, and at least one outputdevice.

These computer programs (also known as programs, software, softwareapplications, or code) include machine instructions for a programmableprocessor, and may be implemented in a high-level procedural and/orobject-oriented programming language, and/or in assembly/machinelanguage. As used herein, the term “machine-readable medium” refers toany computer program product, apparatus, and/or device (e.g., magneticdiscs, optical disks, memory, Programmable Logic Devices (PLDs)) used toprovide machine instructions and/or data to a programmable processor,including a machine-readable medium that receives machine instructionsas a machine-readable signal. The term “machine-readable signal” refersto any signal used to provide machine instructions and/or data to aprogrammable processor.

In various implementations, description is made with reference to thefigures. However, certain implementations may be practiced without oneor more of these specific details, or in combination with other knownmethods and configurations. In the description, numerous specificdetails are set forth, such as specific configurations, dimensions, andprocesses, in order to provide a thorough understanding of theimplementations. In other instances, well-known processes andmanufacturing techniques have not been described in particular detail inorder to not unnecessarily obscure the description. Reference throughoutthis specification to “one embodiment,” “an embodiment,” “oneimplementation, “an implementation,” or the like, means that aparticular feature, structure, configuration, or characteristicdescribed is included in at least one embodiment or implementation.Thus, the appearance of the phrase “one embodiment,” “an embodiment,”“one implementation, “an implementation,” or the like, in various placesthroughout this specification are not necessarily referring to the sameembodiment or implementation. Furthermore, the particular features,structures, configurations, or characteristics may be combined in anysuitable manner in one or more implementations.

The use of relative terms throughout the description may denote arelative position or direction. For example, “distal” may indicate afirst direction away from a reference point. Similarly, “proximal” mayindicate a location in a second direction opposite to the firstdirection. However, such terms are provided to establish relative framesof reference, and are not intended to limit the use or orientation of ananchoring delivery system to a specific configuration described in thevarious implementations.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of what is claimed or of what maybe claimed, but rather as descriptions of features specific toparticular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Only a few examples and implementations are disclosed.Variations, modifications and enhancements to the described examples andimplementations and other implementations may be made based on what isdisclosed.

In the descriptions above and in the claims, phrases such as “at leastone of” or “one or more of” may occur followed by a conjunctive list ofelements or features. The term “and/or” may also occur in a list of twoor more elements or features. Unless otherwise implicitly or explicitlycontradicted by the context in which it is used, such a phrase isintended to mean any of the listed elements or features individually orany of the recited elements or features in combination with any of theother recited elements or features. For example, the phrases “at leastone of A and B;” “one or more of A and B;” and “A and/or B” are eachintended to mean “A alone, B alone, or A and B together.” A similarinterpretation is also intended for lists including three or more items.For example, the phrases “at least one of A, B, and C;” “one or more ofA, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, Balone, C alone, A and B together, A and C together, B and C together, orA and B and C together.”

Use of the term “based on,” above and in the claims is intended to mean,“based at least in part on,” such that an unrecited feature or elementis also permissible.

What is claimed is:
 1. A device for performing an ophthalmic procedurein an eye, the device comprising: a hand-held portion comprising aproximal, reusable portion releasably coupleable to a distal, disposableportion; the proximal, reusable portion comprising: a motor; and arotatable coupler for releasably operatively coupling the motor to thedistal, disposable portion, the distal, disposable portion comprising: adistal, elongate member comprising a lumen and an opening at a distalend region of the elongate member; and a vacuum source driven by themotor and in fluid communication with the opening at the distal endregion of the elongate member, wherein the vacuum source comprises aplurality of pistons, each piston of the plurality of pistons housedwithin a dedicated one of a plurality of cylinders, wherein the vacuumsource is configured to deliver pulses of discontinuous negativepressure to the distal end region of the lumen.
 2. The device of claim1, wherein each of the plurality of cylinders comprises an inlet openingand an outlet opening, the inlet opening in fluid communication with thelumen of the elongate member.
 3. The device of claim 1, wherein thenegative pressure is from 10 inHg up to about 30 inHg.
 4. The device ofclaim 1, wherein the pulses of discontinuous negative pressure have acycling frequency of between about 1 Hz and about 100 Hz.
 5. The deviceof claim 1, wherein a first pulse of negative pressure draws a firstamount of fluid from the lumen of the elongate member into a firstcylinder of the plurality of cylinders through the inlet opening, andwherein a first pulse of positive pressure within the first cylinderexpels the first amount of fluid from the first cylinder through theoutlet opening.
 6. The device of claim 5, wherein a volume of the firstamount of fluid is between about 0.1 mL up to about 1.0 mL.
 7. Thedevice of claim 5, wherein movement of a first piston of the pluralityof pistons in a first direction within the first cylinder creates thefirst pulse of negative pressure, and wherein movement of the firstpiston in a second, opposite direction creates the first pulse ofpositive pressure.
 8. The device of claim 7, further comprising acompliant valve positioned within the inlet opening.
 9. The device ofclaim 8, wherein movement of the first piston a second distance in thesecond, opposite direction seals the inlet opening and transmits anamount of the first pulse of positive pressure through the compliantvalve to the lumen of the elongate member.
 10. The device of claim 9,wherein the amount transmitted causes a second amount of fluid to beexpelled out the opening at the distal end region of the elongatemember.
 11. The device of claim 5, wherein the outlet opening isregulated by a valve.
 12. The device of claim 11, wherein the valve is aball type check valve.
 13. The device of claim 11, wherein the outletopening is in fluid communication with an evacuation chamber.
 14. Thedevice of claim 1, wherein the device further comprises a rotational camassembly operatively coupled to the elongate member and operativelycoupled to the motor, the rotational cam assembly configured tooscillate the elongate member.
 15. The device of claim 14, wherein inuse, the rotational cam assembly causes reciprocation of the elongatemember in a proximal direction with a retraction speed profile and in adistal direction with an extension speed profile, and further whereinthe retraction speed profile is different from the extension speedprofile.
 16. The device of claim 15, wherein an average retraction speedof the elongate member from the retraction speed profile is lower thanan average extension speed of the elongate member from the extensionspeed profile.
 17. The device of claim 14, wherein the rotational camassembly operatively coupled to the elongate member is configured toasymmetrically oscillate the elongate member.
 18. The device of claim17, wherein the extension speed profile comprises a maximum extensionspeed and the retraction speed profile comprises a maximum retractionspeed, and further wherein the maximum retraction speed is less than themaximum extension speed.
 19. The device of claim 14, wherein therotational cam assembly is operatively coupled to the plurality ofpistons, the rotational cam assembly configured to cause the vacuumsource to generate the pulses of discontinuous negative pressure. 20.The device of claim 14, wherein the rotational cam assembly ispositioned within the distal, disposable portion.